NHS BOLTON CLINICAL COMMISSIONING GROUP Public Board …€¦ · GM Gallstones Policy v0.4 Page 2 of 14 . Commissioning Statement . Asymptomatic gallstones Policy Exclusions (Alternative

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NHS BOLTON CLINICAL COMMISSIONING GROUP Public Board Meeting AGENDA ITEM NO: ……8……………… Date of Meeting: ……14th February 2020………… TITLE OF REPORT:

GM Policies for Approval

AUTHOR:

GMSS Effective Use of Resources Team/ Michael Robinson, Associate Director Integrated Governance & Policy

PRESENTED BY:

Jane Bradford, Clinical Director, Governance & Safety

PURPOSE OF PAPER: (Linking to Strategic Objectives)

The paper updates the Board on 3 new GM Policies which have been through the agreed GM Effective Use of Resources governance arrangements and approved by GM Directors of Commissioning in December 2019: • Asymptomatic Gallstones • Rhinosinusitis Rhinitis Sinusitis • D&C and Hysterectomy for heavy menstrual bleeding

LINKS TO CORPORATE OBJECTIVES (tick relevant boxes):

Deliver the outcomes in the Bolton Joint Health and Care Plan.

Ensure compliance with the NHS statutory duties and NHS Constitution.

Deliver financial balance. Regulatory Requirement. √ Standing Item.

RECOMMENDATION TO THE BOARD: (Please be clear if decision required, or for noting)

The Board is asked to approve the policies which will be varied in to our contract with providers and disseminated throughout primary care thereafter.

COMMITTEES/GROUPS PREVIOUSLY CONSULTED:

Greater Manchester Effective Use of Resources Steering Group and associated clinical consultation. Greater Manchester Directors of Commissioning. CCG Executive.

REVIEW OF CONFLICTS OF INTEREST:

Conflicts of Interest are reviewed through the GM governance and consultation processes.

VIEW OF THE PATIENTS, CARERS OR THE PUBLIC, AND THE EXTENT OF THEIR INVOLVEMENT:

Full clinical consultation undertaken as part of this review process.

OUTCOME OF EQUALITY IMPACT ASSESSMENT (EIA) AND ANY ASSOCIATED RISKS:

EIA and an assessment undertaken as part of the GM policy development process.

Greater Manchester EUR Policy Statement on:

Asymptomatic gallstones GM Ref: GM061 Version: 0.4 (12 Sept 2019)

GM Gallstones Policy v0.4 Page 2 of 14

Commissioning Statement

Asymptomatic gallstones

Policy Exclusions (Alternative commissioning arrangements apply)

Common bile duct (CBD) stones may present with symptoms of jaundice, cholangitis or pancreatitis, or be asymptomatic. All CBD stones should be referred for treatment because of the risk of potential severe complications. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Fitness for Surgery

NOTE: All patients should be assessed as fit for surgery before going ahead with treatment, even though funding has been approved.

Policy Inclusion Criteria

Surgical interventions for asymptomatic gallstones (except for those in the common bile duct) are not commissioned NICE states for asymptomatic gallstones “clinicians should reassure people with asymptomatic gallstones found in a normal gallbladder and normal biliary tree that they do not need treatment unless they develop symptoms” Clinicians are expected to diagnose, refer and manage patients in line with NICE CG 188: Gallstone disease: diagnosis and management (see appendix 1 for a summary)

Funding Mechanism Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges

and/or audit of cases against commissioned criteria.

Clinicians can submit an individual funding request outside of this guidance if they feel there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence.

Clinical Exceptionality

Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

https://gmeurnhs.co.uk/Docs/Other%20Policies/GM%20EUR%20Operational%20Policy.pdf


Contents Commissioning Statement ........................................................................................................................ 2

Policy Statement ...................................................................................................................................... 4

Equality & Equity Statement ..................................................................................................................... 4

Governance Arrangements ....................................................................................................................... 4

Aims and Objectives ................................................................................................................................. 4

Rationale behind the policy statement ...................................................................................................... 5

Treatment / Procedure .............................................................................................................................. 5

Epidemiology and Need ........................................................................................................................... 5

Adherence to NICE Guidance .................................................................................................................. 5

Audit Requirements .................................................................................................................................. 5

Date of Review ......................................................................................................................................... 5

Glossary ................................................................................................................................................... 6

References ............................................................................................................................................... 6

Governance Approvals ............................................................................................................................. 6

Appendix 1 – Evidence Review ................................................................................................................ 8

Appendix 2 – Diagnostic and Procedure Codes ...................................................................................... 12

Appendix 3 – Version History ................................................................................................................. 14


Policy Statement The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of surgical treatments of asymptomatic gallstones by CCGs in Greater Manchester by:

mailto:[email protected]




reducing the variation in access to surgical treatments of asymptomatic gallstones.

ensuring surgical treatments of asymptomatic gallstones are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning of surgical treatments of asymptomatic gallstones across Greater Manchester.

promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement Asymptomatic gallstones are very common. No treatment is required unless symptoms or signs develop such as abdominal pains, abdominal discomfort, or jaundice. Any treatment aimed at preventing future complications is not recommended (such as prophylactic cholecystectomy) as the risk of complications from surgical treatment outweighs the potential risk of developing complications from the stones4.

Treatment / Procedure Gallstones are small stones, usually made of cholesterol, that form in the gallbladder. In most cases, they don't cause any symptoms and don't need to be treated. Surgery may remove the entire gallbladder (cholecystectomy), or just the stones from bile ducts. Techniques to remove the gallbladder include: laparoscopic cholecystectomy – 'keyhole' surgery. The surgeon makes small incisions (cuts) through the skin, allowing access for a range of instruments, the surgeon then removes the gallbladder through one of the incisions. Open surgery (laparotomy) – the surgeon reaches the gallbladder through a wider abdominal incision.

Epidemiology and Need In the UK around 10-15% of the adult population have gallstones3. The majority of people with gallbladder stones remain asymptomatic and require no treatment. The definitive treatment of symptomatic gallbladder stones is surgical removal of the gallbladder.

Adherence to NICE Guidance This policy adheres to NICE CG188: Gallstone disease: diagnosis and management.

Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.


Glossary

Term Meaning

Asymptomatic gallstones

the presence of gallstones detected incidentally in patients who do not have any abdominal symptoms or have symptoms that are not thought to be due to gallstones. Diagnosis is made during routine ultrasound for other abdominal conditions or, occasionally, by palpation of the gall bladder at operation. This definition implies that we know which symptoms are specific to gallstones.

Cholelithiasis Gallstones

Common bile duct

The common bile duct is a small, tube-like structure formed where the common hepatic duct and the cystic duct join. Its physiological role is to carry bile from the gallbladder and empty it into the upper part of the small intestine (the duodenum).

Cystic duct The cystic duct transfers bile between the gallbladder and common and hepatic bile ducts.

Hepatic Pertaining to the liver.

Laparoscopic cholecystectomy

The surgeon makes small incisions (cuts) through the skin, allowing access for a range of instruments to remove the gall bladder.

Laparotomy A surgical incision into the abdominal cavity, for diagnosis or in preparation for major surgery.

References 1. Greater Manchester Effective Use of Resources Operational Policy

2. World Gastroenterology Organisation Practice Guideline: Asymptomatic Gallstone Disease

3. Royal College of Surgeons Commissioning guide 2013 Gallstone Disease

4. NICE Clinical Knowledge Summary- Asymptomatic Gallstones

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 20/03/2019


Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning (Delegated authority given to approve policy by Greater Manchester Joint

Commissioning Board)

Bolton Clinical Commissioning Group

Bury Clinical Commissioning Group

Heywood, Middleton & Rochdale Clinical Commissioning Group

Manchester Clinical Commissioning Group

Oldham Clinical Commissioning Group

Salford Clinical Commissioning Group

Stockport Clinical Commissioning Group

Tameside & Glossop Clinical Commissioning Group

Trafford Clinical Commissioning Group

Wigan Borough Clinical Commissioning Group


Appendix 1 – Evidence Review

Asymptomatic gallstones GM061

Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NICE evidence NICE CKS: Gallstones, Last revised: February 2015

NICE guidance

NICE CG188: Gallstone disease: diagnosis and management, Published: 29 October 2014

NICE Quality Standard (QS104): Gallstone disease NICE Quality standard, Published: 3 December 2015 (not cited here)

RCS website RCS Commissioning Guide 2013: Gallstone disease

Summary of the evidence The evidence-based consensus in all of the above guidelines is that the risks of surgery are not outweighed by the benefits for the removal of asymptomatic gallstones with the exception of those found in the common bile duct and as such it should not be considered in the majority of cases.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL 1 : NICE clinical guidelines

NICE CG188: Gallstone disease: diagnosis and management - Published: 29 October 2014 nice.org.uk/guidance/cg188

1 Recommendations

1.1 Diagnosing gallstone disease

1.1.1 Offer liver function tests and ultrasound to people with suspected gallstone disease, and to people with abdominal or gastrointestinal symptoms that have been unresponsive to previous management.


1.1.2 Consider magnetic resonance cholangiopancreatography (MRCP) if ultrasound has not detected common bile duct stones but the:

bile duct is dilated and/or

liver function test results are abnormal.

1.1.3 Consider endoscopic ultrasound (EUS) if MRCP does not allow a diagnosis to be made.

1.1.4 Refer people for further investigations if conditions other than gallstone disease are suspected.

1.2 Managing gallbladder stones

1.2.1 Reassure people with asymptomatic gallbladder stones found in a normal gallbladder and normal biliary tree that they do not need treatment unless they develop symptoms.

1.2.2 Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones.

1.2.3 Offer day-case laparoscopic cholecystectomy for people having it as an elective planned procedure, unless their circumstances or clinical condition make an inpatient stay necessary.

1.2.4 Offer early laparoscopic cholecystectomy (to be carried out within 1 week of diagnosis) to people with acute cholecystitis.

1.2.5 Offer percutaneous cholecystostomy to manage gallbladder empyema when:

surgery is contraindicated at presentation and

conservative management is unsuccessful.

1.2.6 Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystostomy once they are well enough for surgery.

1.3 Managing common bile duct stones

1.3.1 Offer bile duct clearance and laparoscopic cholecystectomy to people with symptomatic or asymptomatic common bile duct stones.

1.3.2 Clear the bile duct:

surgically at the time of laparoscopic cholecystectomy or

with endoscopic retrograde cholangiopancreatography (ERCP) before or at the time of laparoscopic cholecystectomy.

1.3.3 If the bile duct cannot be cleared with ERCP, use biliary stenting to achieve biliary drainage only as a temporary measure until definitive endoscopic or surgical clearance.

1.3.4 Use the lowest-cost option suitable for the clinical situation when choosing between day-case and inpatient procedures for elective ERCP.

Patient, family member and carer information

1.4.1 Advise people to avoid food and drink that triggers their symptoms until they have their gallbladder or gallstones removed.

1.4.2 Advise people that they should not need to avoid food and drink that triggered their symptoms after they have their gallbladder or gallstones removed.

1.4.3 Advise people to seek further advice from their GP if eating or drinking triggers existing symptoms or causes new symptoms to develop after they have recovered from having their gallbladder or gallstones removed. 2. LEVEL 1 RCS : Commissioning guide

RCS : Commissioning guide 2013 Gallstone disease 1 High value care pathway for gallstone disease

1.1 Primary care

Non-referral

Patients with an incidental finding of stones in an otherwise normal gallbladder require no further investigation or referral.

Primary care management


Most patients with symptomatic gallstones present with a self-limiting attack of pain that lasts for hours only. This can often be controlled successfully in primary care with appropriate analgesia, avoiding the requirement for emergency admission. When pain cannot be managed or if the patient is otherwise unwell (e.g. sepsis), he or she should be referred to hospital as an emergency.

Further episodes of biliary pain can be prevented in around 30% of patients by adopting a low fat diet. Fat in the stomach releases cholecystokinin, which precipitates gallbladder contraction and might result in biliary pain.

Patients with suspicion of acute cholecystitis, cholangitis or acute pancreatitis should be referred to hospital as an emergency.

There is no evidence to support the use of hyoscine or proton pump inhibitors in the management of gallbladder symptoms. Antibiotics should be reserved for patients with signs of sepsis.

There is no evidence of benefit from the use of non-surgical treatments in the definitive management of gallbladder stones (e.g. gallstone dissolution therapies, ursodeoxycholic acid or extracorporeal lithotripsy).

Best practice referral guidelines

Epigastric or right upper quadrant pain, frequently radiating to the back, lasting for several minutes to hours (often occurring at night) suggests symptomatic gallstones. These patients should have liver function tests checked and be referred for ultrasonography.

Confirmation of symptomatic gallstones should result in a discussion of the merits of a referral to a surgical service regularly performing cholecystectomies.

Following treatment for CBD stones with endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy, removal of the gallbladder should be considered in all patients. However, in patients with significant co-morbidities, the risks of surgery may outweigh the benefits.

Patients with known gallstones with a history of acute pancreatitis should be referred for a cholecystectomy to a surgical service regularly performing the procedure.

Patients with known gallstones and jaundice or clinical suspicion of biliary obstruction (e.g. significantly abnormal liver function tests) should be referred urgently to a gastroenterology or surgical service with expertise in managing biliary diseases.

1.2 Secondary care

In patients with symptomatic gallstones, the decision to operate is made by the patient with guidance from the surgeon. This will include assessment of the risk of recurrent symptoms and complications of the gallstones (50% risk per annum of further episode of biliary colic and 1–2% risk per annum of development of serious complications), and the risks and complication rates of surgery in relation to the individual patient’s co-morbidities and preference.

Patients with acute gallstone pancreatitis should undergo definitive treatment (usually cholecystectomy although an endoscopic sphincterotomy may be appropriate in frail patients) within two weeks of recovery from the incident episode, as described in the UK guidelines for the management of acute pancreatitis.

If the cause of abnormal liver function tests +/- dilated bile ducts is unclear on initial imaging, further investigation is required. This will usually be with preoperative magnetic resonance cholangiopancreatography or endoscopic ultrasonography. ERCP should be reserved for therapy, not as a diagnostic test for bile duct stones. Preoperative on-table cholangiography is an alternative strategy in units that offer laparoscopic bile duct exploration.

Patients with symptomatic CBD stones should undergo CBD stone extraction by ERCP or surgical bile duct exploration (laparoscopic or open). Patients with asymptomatic CBD gallstones should also be considered for stone extraction.

The majority of people with gallbladder stones remain asymptomatic and require no treatment

Patients with an incidental finding of stones in an otherwise normal gallbladder require to further intervention or referral

The laparoscopic approach to cholecystectomy should be considered the standard for the majority of patients.


Secondary providers offering cholecystectomy must be able to offer intraoperative on-table cholangiography and have arrangements in place for urgent access to ERCP and interventional radiology for the management of postoperative complications.

Patients who have a suspected bile duct injury should be referred to their regional tertiary hepatopancreatobiliary service.

3. LEVEL N/A: NICE CLINICAL KNOWLEDGE SUMMARY

NICE CKS: Gallstones, Last revised: February 2015 Scenario: Asymptomatic gallstones

Scenario: Management of people with asymptomatic gallstones

Age from 18 years onwards

How do I manage a person with asymptomatic gallstones?

For a person with asymptomatic gallstones found in a normal gallbladder, and with a normal biliary tree, explain to the person that:

o Asymptomatic gallstones are very common.

o No treatment is required unless symptoms or signs develop such as abdominal pains, abdominal discomfort, or jaundice, when they should seek medical advice.

o Any treatment aimed at preventing future complications is also not recommended (such as prophylactic cholecystectomy) as the risk of complications from surgical treatment outweighs the potential risk of developing complications from the stones.

For a person with asymptomatic gallstones found in the common bile duct, explain to the person that:

o Although they are asymptomatic, there is a significant risk of developing serious complications such as cholangitis or pancreatitis.

o Therefore, they should be managed the same as a person with Symptomatic gallstones with common bile duct stones.

Basis for recommendation

No treatment for asymptomatic gallstones in a normal gallbladder with a normal biliary tree

The recommendation that treatment is not required is based on the National Institute for Health and Care Excellence (NICE) guideline Gallstone disease: Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis[NICE, 2014].

This is consistent with the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland Commissioning guide: gallstone disease which states that 'patients with an incidental finding of stones in an otherwise normal gallbladder require no further investigation or referral' [Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, 2013].

Treatment for asymptomatic gallstones found in the common bile duct

The recommendation that treatment is required is based on the NICE guideline Gallstone disease: Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis [NICE, 2014].

This is consistent with the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland Commissioning guide: gallstone disease which states that 'all common bile duct stones should be referred for treatment because of the risk of potential severe complications' [Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, 2013].

https://cks.nice.org.uk/gallstones#!scenariorecommendation:1

https://cks.nice.org.uk/gallstones#!references/-619303







Appendix 2 – Diagnostic and Procedure Codes Asymptomatic gallstones

GM061

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM061 – Asymptomatic gallstones

OPCS-4 Procedure Codes:

Total cholecystectomy and excision of surrounding tissue J181

Total cholecystectomy and exploration of common bile duct J182

Total cholecystectomy NEC J183

Partial cholecystectomy and exploration of common bile duct J184

Partial cholecystectomy NEC J185

Other specified excision of gall bladder J188

Unspecified excision of gall bladder J189

Laparoscopically assisted approach to abdominal cavity (when secondary to J18; J19; J20) Y751

Endoscopic removal of calculus from liver using laparoscope (Must have Z302 following it) J081

Gall bladder (must appear secondary to J081) Z302

Open removal of calculus from gall bladder J211

OPCS-4 Procedure Codes (that might be used)

Drainage of gall bladder J212

Excision of lesion of gall bladder J231

Percutaneous drainage of gall bladder J241

Percutaneous fragmentation of calculus in gall bladder J242

Percutaneous dissolution therapy to calculus in gall bladder J243

Extracorporeal fragmentation of calculus in gall bladder J261

Open removal of calculus from bile duct and drainage of bile duct J331

Open removal of calculus from bile duct NEC J332

Direct puncture operative cholangiography J373

Endoscopic sphincterotomy of sphincter of Oddi and removal of calculus HFQ J381

Endoscopic sphincterotomy of sphincter of Oddi and insertion of tubal prosthesis into bile duct

J382

Endoscopic retrograde insertion of tubal prosthesis into bile duct NEC J402

Endoscopic retrograde insertion of expanding covered metal stent into bile duct J405


Endoscopic retrograde insertion of expanding metal stent into bile duct NEC J406

Endoscopic retrograde extraction of calculus from bile duct J411

Endoscopic dilation of bile duct NEC J412

Endoscopic retrograde lithotripsy of calculus of bile duct J413

Endoscopic retrograde photodynamic laser therapy of lesion of bile duct J414

Percutaneous dilation of anastomosis of bile duct and insertion of tubal prosthesis HFQ J461

Extracorporeal lithotripsy of calculus in bile duct J521

Laparoscopic ultrasound examination of bile duct and biopsy of lesion of bile duct J511

Other specified laparoscopic ultrasound examination of bile duct J518

Unspecified laparoscopic ultrasound examination of bile duct J519

Endoscopic ultrasound examination of bile duct and biopsy of lesion of bile duct J531

Other specified endoscopic ultrasound examination of bile duct J538

Unspecified endoscopic ultrasound examination of bile duct J539

Magnetic resonance cholangiopancreatography U162

With the following ICD-10 diagnosis code(s):

Calculus of gallbladder without cholecystitis K802

ICD-10 (Exceptions)

Calculus of gallbladder with acute cholecystitis K800

Calculus of gallbladder with other cholecystitis K801

Calculus of bile duct with cholangitis K803

Calculus of bile duct with cholecystitis K804

Calculus of bile duct without cholangitis or cholecystitis K805

Other cholelithiasis K808

Biliary acute pancreatitis K851


Appendix 3 – Version History Asymptomatic Gallstones

GM061 The latest version of this policy can be found here [To add link when final policy approved]

Version Date Summary of Changes

0.1 08/11/2018 Initial draft

0.2 21/11/2019 Policy approved at GM EUR Steering Group to progress to Clinical Engagement with no amendments needing to be made.

0.3 20/03/2019 GM EUR Steering Group reviewed the clinical engagement feedback and agreed the following changes to the policy:- Policy Exclusions – ‘Clinicians are expected to diagnose, refer and manage patients in line with NICE CG188: Gallstone disease: diagnosis and management (see Appendix 1 for a summary).’ replaced with ‘NICE states for asymptomatic gallstones “ clinicians should reassure people with asymptomatic gallstones found in a normal gallbladder and normal biliary tree that they do not need treatment unless they develop symptoms”’ Evidence Review Section - The following 2 bullet point have been added to:- 2. Level 1 RCS: Commissioning Guide

1.2 Secondary care (as bullet points 5 & 6)

The majority of people with gallbladder stones remain asymptomatic and require no treatment

Patients with an incidental finding of stones in an otherwise normal gallbladder require to further intervention or referral

In the second sentence of the 4th bullet point ‘CBD’ has been added between asymptomatic and gallstones. Following the above changes the GM EUR Steering Group approved the policy to progress through the governance process.

0.4 12/09/2019 Procedure and Diagnostic codes added to Appendix 2 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

https://www.nice.org.uk/guidance/cg188

https://www.nice.org.uk/guidance/cg188



Referral to secondary care for the further management of Rhinosinusitis / Rhinitis / Sinusitis GM Ref: GM065 Version: 0.5 (12 September 2019)

GM Rhinosinusitis Policy v0.5 DRAFT Page 2 of 30


Referral to secondary care for the further management of Rhinosinusitis / Rhinitis / Sinusitis


Prescribing for rhinitis / sinusitis is the remit of GMMMG and is not covered by this policy. NICE NG79: Sinusitis (acute): antimicrobial prescribing should also be referred to where appropriate. Any cases where there is any suspicion that malignancy may be the diagnosis should be referred using the cancer pathway. NOTE: the higher incidence of nasopharyngeal cancer in individuals of South East Asian origin5.

Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Fitness for Surgery


Best Practice Guidelines

All providers are expected to follow best practice guidelines (where available) in the management of these conditions.


Urgent referrals

Patients with rhinitis who have unilateral symptoms, heavily blood stained discharge or pain, require ENT referral. Arrange admission if acute sinusitis is associated with a severe systemic infection, or a serious complication including:

Orbital involvement — indicated by peri-orbital oedema or cellulitis, a displaced globe, double vision, ophthalmoplegia, or reduced visual acuity.

Intracranial involvement — indicated by severe frontal headache, swelling over the frontal bone, symptoms or signs of meningitis, or focal neurological signs.

Other referrals

Those with nasal blockage unrelieved by pharmacotherapy or structural abnormalities, such as septal deviation, sufficient to render nasal therapy difficult should be seen by a surgeon. Prior to referral

Primary care assessment

Take a history documenting the symptoms including those areas listed below:

Two or more persistent symptoms for at least 12 weeks, one of which should be nasal obstruction and/or discharge and/or must include: facial pain/pressure or anosmia

Assessment of severity of symptoms into mild or moderate/severe. This can be facilitated by using a 10cm Visual Analogue Scale (VAS) to categorise into mild (VAS 0 – 3) or moderate/severe (VAS >3)

Examination of anterior nasal cavity, using headlight or otoscope any unilateral findings should raise suspicion of neoplasia

Look for visible nasal polyps (consider turbinate hypertrophy in differential diagnosis)

Consider diagnosis of allergic rhinitis in patients (especially those with family history

https://www.nice.org.uk/guidance/ng79


of atopy) with associated epiphora, itching, sneezing in addition to rhinorrhoea – manage according to ARIA guidelines, non-allergic rhinitis (congestion and clear rhinorrhoea), drug-induced rhinitis, structural deformity and other aetiologies (see BSACI guideline)

Assess for lower airway symptoms and control of asthma

Consider alternate diagnosis in presence of unilateral symptoms, cacosmia, crusting, epistaxis, serosanguinous or blood-stained discharge, orbital symptoms (diplopia, reduced visual acuity, globe displacement, peri-orbital oedema) or neurological symptoms (severe frontal headache, signs of symptoms of meningism, neurological signs) – consider urgent referral in these cases

There is no role for plain X-ray in assessment of chronic rhinosinusitis (plain X-ray, despite low cost and availability, has limited usefulness due to underestimation of bony and soft tissue sinus pathology). CT imaging is usually reserved for those who fail medical therapy as an aid to surgical management or have complicated infection/more serious conditions and should not be used routinely in primary care.

See RCS / ENT UK Commissioning Guidelines for more detail. Referral to secondary care

Refer to secondary care for persistent moderate /severe symptoms after 3 months of primary care management:

Prior to referral assess treatment compliance and technique

Refer to specialist community or secondary care provider for nasal endoscopy and further investigation if persistent symptoms of chronic rhinosinusitis despite compliance with medical therapy

Either a community specialist or secondary care specialist may perform endoscopic examination

CT imaging is normally reserved for patients selected for surgical management in order to minimize risk from exposure to ionizing radiation, and therefore not recommended for use in primary care or at this stage of the treatment pathway

Patients management prior to referral

Saline irrigation: commercially available positive pressure squeeze bottles or irrigation jugs (Netti pots) available to aid douching. High volume irrigation more effective than saline sprays (Appendix 1)

Intranasal corticosteroids (INCS): advise on correct application technique. Bioavailability varies between INCS – negligible with mometasone and fluticasone. It is essential to explain correct technique (see Appendix 1) and the need for compliance

Informed choice over treatment options is essential; patients should be provided with written information on rhinosinusitis (e.g. NHS Choices or equivalent) and actively engaged in treatment decisions

For those who respond to medical treatment, there is no need to offer surgery as outcomes have been shown to be equivalent. In secondary care

CT imaging is mandatory before surgery if not performed earlier in care pathway (does not need to be repeated if no intervening surgical intervention). In suitable patients, endoscopic sinus surgery may be performed in an ambulatory setting.

https://www.entuk.org/commissioning-guides


ESS not usually indicated When LM<41 and an alternate diagnosis should be considered. ESS not indicated if no evidence of sinus disease on CT imaging (LM=0). There is no significant evidence to support the use of frequent post-operative debridement of the sinus cavities.

When reading a CT scan of the paranasal sinuses and ostiomeatal complex, the reader assigns each sinus a score of:

0 (no abnormality)

1 (partial opacification)

2 (complete opacification) The ostiomeatal complex is assigned a score of either 0 (not obstructed) or 2 (obstructed). See RCS / ENT UK Commissioning Guidelines for more detail.

Funding Mechanism

GMEURSG recommendation: Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: These referrals may be the subject of contract challenges and/or audit of cases against commissioned criteria.



1 The Lund-Mackay score is a widely used method for radiologic staging of chronic rhinosinusitis.

https://radiopaedia.org/articles/paranasal-sinuses

https://radiopaedia.org/articles/ostiomeatal-complex



https://radiopaedia.org/articles/chronic-sinusitis












Date of Review ......................................................................................................................................... 8

Glossary ................................................................................................................................................... 9

References ............................................................................................................................................. 12

Governance Approvals ........................................................................................................................... 12

Appendix 1 – Evidence Review .............................................................................................................. 13






Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy. .

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:





reducing the variation in access to treatments/procedures.

ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester.


Rationale behind the policy statement Chronic rhinitis is increasingly common – this policy aims to ensure that secondary care resources are targeted at those patients who cannot be adequately managed in primary care. Sinusitis both chronic and acute is a common problem. The policy aims to ensure that referral for investigation and management in secondary care is appropriately targeted. Chronic rhinosinusitis is a highly prevalent condition affecting 10% of the UK adult population. The policy aims to ensure that referral for investigation and management in secondary care is appropriately targeted.

Treatment / Procedure Rhinosinusitis

Rhinosinusitis is defined as inflammation of the nose and paranasal sinuses. In acute rhinosinusitis, there is complete resolution of symptoms within 12 weeks of onset; persistence of symptoms for more than 12 weeks is categorised as chronic rhinosinusitis. Acute rhinosinusitis usually has an infective aetiology. The aetiology of chronic rhinosinusitis is largely unknown but is likely to be multifactorial, with inflammation, infection and obstruction of sinus ventilation playing a part. Diagnosis is made by the presence of two or more persistent symptoms for at least 12 weeks, one of which should be nasal obstruction and/or nasal discharge, and/or facial pain/pressure or anosmia Chronic rhinosinusitis is sub-categorised by the presence or absence of nasal polyps (CRSwNP or CRSsNP respectively) Allergic (Chronic) Rhinitis

Allergic rhinitis is common and affects 10–15% of children and 26% of adults in the UK, it affects quality of life, school and work attendance, and is a risk factor for development of asthma. Allergic rhinitis is diagnosed by history and examination, supported by specific allergy tests. Topical nasal corticosteroids are the treatment of choice for moderate to severe disease. Combination therapy with intranasal corticosteroid plus intranasal antihistamine is more effective than either alone and provides second line treatment for those with rhinitis poorly controlled on monotherapy. Immunotherapy is highly effective when the specific allergen is the responsible driver for the symptoms. Treatment of rhinitis is associated with benefits for asthma. Non-allergic rhinitis also is a risk factor for the development of asthma and may be eosinophilic and steroid-responsive or neurogenic and noninflammatory. Non-allergic rhinitis may be a presenting complaint for systemic disorders such as granulomatous or eosinophilic polyangiitis, and sarcoidoisis. Infective rhinitis can be caused by viruses, and less commonly by bacteria, fungi and protozoa. Chronic Sinusitis


Chronic sinusitis is inflammation of the paranasal sinuses lasting more than 12 weeks. Symptoms include: facial pressure, rhinorrhoea, postnasal drainage, congestion, and general malaise. Chronic sinusitis is divided into 2 groups, with and without polyps, which have slightly different treatment regimens Clinical evaluation: Historical features that should be elicited include duration of past and current nasal symptoms, exacerbating/relieving factors, previous nasal/paranasal sinus surgery, current medications, previous treatments, and duration. The presence of symptoms suggestive of concomitant allergic rhinitis (seasonal or perennial itching, sneezing, clear rhinorrhoea, congestion, or ocular irritation) and asthma should be established. On examination, palpation of areas overlying the maxillary and frontal (forehead) sinuses can induce pain if infected. However, this is not consistent in all patients and is more meaningful in acute rather than chronic sinusitis.

Epidemiology and Need Rhinosinusitis

Chronic rhinosinusitis is a highly prevalent condition affecting 10% of the UK adult population. It is associated with significant reduction of quality of life, high health-care utilisation and significant absenteeism/presenteeism. Chronic Rhinitis2

In the UK, rhinitis prevalence is 10.1% and 15.3% in 6-7 and 13 to 14 year olds respectively, and 26% in UK adults. Peak prevalence occurs in the 3rd and 4th decades, with some evidence for remission during adult life. The prevalence in the UK and Western Europe has increased dramatically over the past 4-5 decades. Some studies suggest a plateau may have been reached, whilst others report continued increases since the 1990s. There is a male preponderance before adolescence reversing post-adolescence. World-wide, there appears to be a correlation between economic and industrial development and the prevalence of Allergic Rhinitis (AR). Post-communist Eastern Europe has seen an accelerating occurrence. Local AR, confirmable only by nasal provocation, has been found to have a prevalence of over 25% in some centres. A prevalence ratio of allergic to non-allergic rhinitis of 3:1 has been suggested. Rhinitis is strongly associated with asthma: 74%-81% of asthmatics report symptoms of rhinitis. Rhinitis, both allergic and non-allergic, is a strong risk factor for new-onset asthma. Chronic Sinusitis3

There are estimated to be 25 cases of chronic sinusitis per 10,000 person-years in an average GP surgery in the UK. It occurs in all ages, both genders, and all ethnic groups. In the US, it is the most common chronic illness, with almost 30 million Americans affected. Prevalence seems to be increasing in women and individuals living in the southern US. Loss of productivity and missed work/school are a major economic factor, with patients suffering a significant decrease in quality of life. Quality-of-life scores are worse than those of other chronic diseases such as heart failure, asthma, and COPD

Adherence to NICE Guidance There are no clinical guidelines for the overall management of these conditions. NICE Clinical knowledge summaries were referenced in the production of this policy




Glossary

Term Meaning

Acute Of abrupt onset.

Aetiology / Aetiologies The cause or series of events that lead to the development of a medical condition.

Allergen Something that triggers an allergic response.

Anosmia Loss of the sense of smell.

Anterior nasal cavity The area inside the nose connecting the nostrils to the airway.

Antihistamine A type of medicine often used to treat allergies.

ARIA guidelines Allergic Rhinitis and its impact on Asthma guidelines

Asthma Common long term inflammatory disease of the airways of the lungs resulting in difficulty breathing.

Atopy Allergic tendency.

Cacosmia Perception of a bad smell .

Cellulitis Infection involving the inner layers of the skin.

Chronic Persisting for a long time or constantly reoccurring.

Concomitant Occurring at the same time.

Corticosteroid A class of steroid hormones used to treat inflammation and other conditions.

Crs Chronic rhinosinusitis

CRSsNP Chronic rhinosinusitis without nasal polyps

CRSwNP Chronic rhinosinusitis with nasal polyps

CT imaging / CT scan Diagnostic tool using computer tomography.

Debridement Removal of dead skin and foreign bodies from an area of the human body.

Diagnostic criteria Symptoms and signs used to diagnose a condition.

Differential diagnosis The different diagnosis that could be made from an individual set of symptoms and signs.


Diplopia Double vision

Discharge A secretion from an area of the body.

Disorder Physical or mental condition that is neither normal or healthy.

Drug-induced rhinitis Rhinitis as a side effect of drug use (see rhinitis)

Endoscopy/ Endoscopic examination

Internal examination using a flexible tube.

ENT Ear nose and throat medical specialty.

Eosinophilic polyangiitis An extremely rare autoimmune condition that causes inflammation of small and medium sized blood vessels in a person with a history of airway allergic hypersensitivity.

Epiphora Excessive watering of the eye.

Epistaxis Nose bleed

Endoscopic Sinus Surgery (ESS)

Sinus surgery carried out using and endoscope (flexible tube).

Focal neurological signs Signs of a disorder of the central nervous system that affect one area of the body only.

Frontal (See ‘Sinuses’ below)

The sinuses situated behind the brow ridges.

General malaise A feeling of being unwell (non-specific).

Globe displacement Something that causes the eyeball to sit in the wrong place.

Granulomatous A collection of immune cells that form in a tissues when the immune system attempts to wall off substances it see as foreign but can’t remove from the body.

Immunotherapy A treatment helping the immune system to target a condition better.

Inflammation The release of chemicals by the body into a tissue which increase the blood flow to that tissue in order to heal injury of infection often resulting in redness and warmth.

Intracranial involvement Involvement of the structures within the skull.

Intranasal Within the nose.

Ionizing radiation Radiation with enough energy to liberate electrons from atoms or molecules resulting in ions.

LM See footnote on page 3

Maxillary (See ‘Sinuses’ below)

The four sinuses (two) either side of the nose.

Meningism The three symptoms showing inflmation of the lining of the brain: neck stiffness, intolerance of light and headache.

Monotherapy A single treatment used on its own for a specific condition.


Multifactorial Involving or depending on a number of factors.

Nasal Pertaining to the nose.

Nasal polyps Non-cancerous growths within the nose or sinuses.

Neoplasia / Malignancy Cancer

Neurogenic Caused or controlled by/arising in the nervous system.

Neurological signs / symptoms

Signs or symptoms caused by disorders of the central nervous system.

Ocular Pertaining to the eye

Opacification Where the sinuses appears cloudy on an X-ray.

Ophthalmoplegia Paralysis of muscles within or around the eye.

Orbital The cavity in the skull which contains the eye.

Ostiomeatal complex The sinuses and the channels that link them.

Otoscope An instrument for looking in the ears and nose.

Paranasal (See ‘Sinuses’ below)

Sinuses around the nose.

Perennial Lasting or existing for a long time.

Peri-orbital oedema Swelling of the tissues around the eye.

Pharmacotherapy Treatment of a disorder with drugs.

Postnasal drainage / drip Excessive mucus, produced the nose, accumulating at the back of the nose and throat.

Primary care Care provided by GPs and others in the community.

Protozoa A single cell, microscopic animal.

Reduced visual acuity Reduced clarity of vision

Rhinitis Irritation and inflammation of the lining of the nose.

Rhinorrhoea Runny noses

Rhinosinusitis Irritation and inflammation of the lining of the nose and sinuses.

Sarcoidoisis An abnormal collection of inflammatory cells forming lumps.

Secondary care Hospital care (not highly specialized)

Septal deviation The tissues dividing the nostrils are deviated to one side often causing blockage one nostril.

Serosanguinous Containing or relating to both blood and the liquid part of blood (serum).

Sinus(es) / Sinus cavities

Air cavities within the bones of the face.

Sinusitis Inflammation of the sinuses.


Systemic Affecting the entire body.

Topical Medicine that is applied to a particular place on or in the body, usually skin or mucous membranes.

Turbinate hypertrophy Enlargement of the structures (turbinates) in the nasal cavity which are part of the air filtration system of the nose.

Unilateral symptoms Symptoms that affect one side of the face only.

Visual Analogue Scale (VAS)

A scale using a visual system to score the level of pain felt by an individual.

References

1. GM EUR Operational Policy

2. NICE CKS: Allergic Rhinitis (Last revised in October 2015)

3. BMJ Best Practice: Chronic sinusitis (Last reviewed: June 2018: Last updated: November 2017)

4. NICE CKS: Sinusitis (Last revised in October 2017)

5. Chin J Cancer. 2011 Feb; 30(2): 114–119. The prevalence and prevention of nasopharyngeal

carcinoma in China Su-Mei Cao et al


Name Date Approved


Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning (Delegated authority given to approve policy by Greater Manchester Joint

Commissioning Board)











https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4013340/

https://www.ncbi.nlm.nih.gov/pubmed/?term=Cao%20SM%5BAuthor%5D&cauthor=true&cauthor_uid=21272443


Appendix 1 – Evidence Review

Referral to secondary care for the further management of Rhinosinusitis / Rhinitis / Sinusitis GM065


Database Result

Royal College of Surgeons website

Royal College of Surgeons / ENT UK Commissioning Guide 2016: Chronic Rhinosinusitis

NICE evidence search

NICE CKS: Sinusitis (Last revised in October 2017)

BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007)

BMJ Best Practice: Chronic sinusitis (Last reviewed: June 2018: Last updated: November 2017)

Summary of the evidence Treatment entails a trial of maximum medical therapy, with surgery reserved for recalcitrant cases, after the diagnosis is confirmed by radiology and after an appropriate trial of treatment. Current evidence suggest that the benefits of surgery are greatest in patients undergoing surgery at an early stage in their disease; therefore once medical therapy has been deemed to have failed there should be no further delay in referral . Patients undergoing surgery within 12 months of onset of symptoms that fail to respond to maximum medical therapy, achieve significantly better measured outcomes in terms on improvements in SNOT-22 than those undergoing surgery at a later stage. Health care utilisation is significantly lower in first 2 years following surgery in patients undergoing surgical intervention compared with those having surgery at a later stage.

The evidence

Levels of evidence







1. LEVEL N/A: NICE Clinical Knowledge Summary NICE CKS: Sinusitis (Last revised in October 2017)

Scenario: Acute sinusitis

Age from 3 months onwards

Management

Arrange admission if acute sinusitis is associated with a severe systemic infection, or a serious complication including:

o Orbital involvement — indicated by peri-orbital oedema or cellulitis, a displaced globe, double vision, ophthalmoplegia, or reduced visual acuity.

o Intracranial involvement — indicated by severe frontal headache, swelling over the frontal bone, symptoms or signs of meningitis, or focal neurological signs.

Recommend measures to relieve symptoms, including:

o Paracetamol or ibuprofen — to reduce pain and fever.

Consider prescribing an intranasal corticosteroid for people with symptoms lasting longer than 10 days or severe symptoms.

o High-dose intranasal corticosteroids have a clinically modest but statistically significant effect in reducing symptoms. For people over the age of 12 with more severe or prolonged symptoms (lasting longer than 10 days) this modest benefit may be considered worthwhile.

Explain that acute sinusitis is caused by a virus in more than 98% of people, takes on average 2.5 weeks to resolve, and that antibiotics are only likely to help when there are features indicative of bacterial infection.

Acute sinusitis usually follows a common cold, and symptoms for less than around 10 days are more likely to be associated with a cold rather than viral or bacterial acute sinusitis.

An antibiotic prescription should not be offered to people presenting with acute sinusitis symptoms for around 10 days or less. Prolonged symptoms (for around 10 days or more with no improvement) could be due to either viral or bacterial acute sinusitis. Viral acute sinusitis is more likely, but even bacterial sinusitis is usually self-limiting and does not routinely need antibiotics.

Only prescribe an antibiotic immediately for people with acute sinusitis who have a co-morbidity that puts them at high risk for a complication, or when acute bacterial sinusitis is suspected.

o For adults, if an antibiotic is indicated prescribe:

Phenoxymethylpenicillin 500mg four times a day for 5 days

If the person is systemically unwell or has symptoms or signs of a more serious illness or is at high risk of complications prescribe:

o Co-amoxiclav 500/125mg 3 times a day for 5 days.

o Alternatives to co-amoxiclav are doxycycline or clarithromycin if the person has a known allergy to penicillin, for 5 days.

o If there is no improvement after 2-3 days of treatment with a first-line antibiotic, or if it is poorly tolerated, consider the following second-line treatments:

Co-amoxiclav (500/125 mg three times a day) for 5 days. (If co-amoxiclav has been used as the first line choice, consult microbiology for advice on second line antibiotic choice.)

An alternative second choice antibiotic (such as azithromycin) if the person is allergic to penicillin or is intolerant of the first choice antibiotic.

Seek specialist advice if the second-line antibiotic is ineffective.

Advise people to make a follow-up appointment if their symptoms rapidly deteriorate, or they develop a high temperature or marked local pain which is predominately unilateral.

For children and young people under 18 years of age. If an antibiotic is indicated prescribe:

o First line - phenoxymethylpenicillin.

o First line - if the child or young person is unwell with symptoms or signs of a more serious illness or is at high risk of complications

https://cks.nice.org.uk/sinusitis#!scenarioclarification

https://cks.nice.org.uk/sinusitis#!scenarioclarification


Co-amoxiclav

Clarithromycin (if the child or young person has a known allergy or intolerance to penicillin)

Doxycycline (only in young people over the age of 12)

o Second line - if symptoms worsen on first line antibiotic for at least 2-3 days

Co-amoxiclav (If co-amoxiclav has been used as the first line choice, consult microbiology for advice on second line antibiotic choice).

An alternative second choice antibiotic if the child or young person is allergic to penicillin or is intolerant of the first choice antibiotic.

Seek specialist advice if the second-line antibiotic is ineffective.

For people with frequent recurrent episodes of sinusitis (more than three episodes requiring antibiotics a year) consider routine referral to an Ear, Nose, and Throat (ENT) specialist.

Treatments that are not recommended include:

o Steam inhalation.

o Oral corticosteroids.

o Antihistamines (unless there is co-existing allergic rhinitis).

o Complementary and alternative medicine (as the benefits have not been proven).

o Mucolytics.

Co-morbidities

The National Institute for Health and Care Excellence (NICE) defines this group as:

o People with a pre-existing co-morbidity, such as:

Significant heart, lung, renal, liver, or neuromuscular disease.

Immunosuppression.

Cystic fibrosis.

o People with acute cough who are older than 65 years of age with two of the following risk factors, or older than 80 years of age with one of the following risk factors:

Hospitalization in the previous year.

Type 1 or type 2 diabetes.

Congestive heart failure.

Current use of oral corticosteroids.


When to admit

The recommendation to arrange hospital admission if acute sinusitis is associated with a severe systemic infection, or a serious complication is based on the opinion of experts of the European Position Statement 2012 group (EPOS 2012), published in the European guidance: European position paper on rhinosinusitis and nasal polyps [Fokkens et al, 2012] and NICE guidance on Sepsis: recognition, diagnosis and early management [NICE, 2016 ].

The most important concern with sinusitis is the development of a complication, which can lead to blindness or even death. Complications are estimated to occur with a frequency of 1 in 10,000 cases of sinusitis [Balk et al, 2001].

When to prescribe an antibiotic

The recommendations on when to prescribe an antibiotic are based on NICE guidance on Sinusitis (acute): antimicrobial prescribing [NICE, 2017].

Acute sinusitis usually follows a common cold, and symptoms for less than around 10 days are more likely to be associated with a cold rather than viral or bacterial acute sinusitis. NICE therefore recommended that 'an antibiotic prescription should not be offered to people presenting with acute sinusitis symptoms for around 10 days or less'. Prolonged symptoms (for around 10 days or more with no improvement) could be due to either viral or bacterial acute sinusitis. Viral acute sinusitis is more likely, but even bacterial sinusitis is usually self-limiting and does not routinely need antibiotics. NICE recognise that people with symptoms that worsen rapidly or significantly should be reassessed

https://cks.nice.org.uk/sinusitis#!references/1350547





to rule out alternative diagnoses and to identify any signs or symptoms suggesting a more serious illness or condition.

The recommendation to prescribe antibiotics in people who have serious co-morbidities, or other combinations of risk factors, is based on the expert opinion of the Guideline Development Group (GDG) of the National Institute for Health and Clinical Excellence (NICE) that prescribing an antibiotic reduces the risk of a serious complication in people with these risk factors [NICE, 2008b].

Antibiotic effectiveness and harms

There is some evidence from RCTs that antibiotics are of limited benefit in the treatment of sinusitis, with between 7 and 14 people requiring treatment for one person to benefit, depending mainly on the initial accuracy of diagnosis.

First-line antibiotic choice

There is no evidence from RCTs to support the use of one antibiotic over another. In the absence of trial data, antibiotic selection should be made with respect to local resistance patterns, with consideration given to practical issues such as convenience of the regimen, adverse effects, and cost. The NICE GDG advise that this 'recommendation is based on very low to moderate quality evidence from two systematic reviews and meta-analyses of RCTs in adults [Ahovuo-Saloranta, 2014; Karageorgopoulos et al, 2008]. They also note that 'phenoxymethylpenicillin and amoxicillin were similar in terms of cure and improvement at 10 days (2 RCTs from the systematic reviews; moderate to high quality evidence) and 14 to 16 days (1 RCT from the systematic reviews; moderate quality evidence). There was no significant difference in duration of illness in 2 RCTs and in 1 RCT the duration of illness was significantly lower with either amoxicillin or phenoxymethylpenicillin, compared with placebo (moderate quality evidence).

o Phenoxymethylpenicillin is also recommended based on expert opinion of the Health Protection Agency and British Infection Association [HPA and British Infection Association, 2013].

o Doxycycline, erythromycin, or clarithromycin are recommended based on expert opinion, if there is a known history of allergy to penicillin because:

Doxycycline is active against both S. pneumoniae and H. influenzae [Chopra, 2003; HPA and British Infection Association, 2013], is available as a convenient, once-daily regimen (after an initial loading dose), is well tolerated by most people, and is relatively inexpensive.

Erythromycin and clarithromycin are active against most of the bacterial pathogens involved in sinusitis [Bryskier and Butzler, 2003], although resistance to them is increasing, especially for H. influenzae. Erythromycin is the preferred choice in pregnant women as there is extensive experience of its use in pregnancy. Paediatric formulations of erythromycin are also less expensive than clarithromycin [BNF 65, 2013]. Clarithromycin is generally thought to be better tolerated than erythromycin [Aronson, 2006], and also has a more convenient dosing regimen [DTB, 1991].

Second-line antibiotic choice

NICE and the Health Protection Agency and British Infection Association recommend using co-amoxiclav second-line in people with persistent symptoms [HPA and British Infection Association, 2013]. NICE also recommend that if the person does not respond to a first-line antibiotic within 2-3 days, they should be given a second-line antibiotic.

Antibiotic duration and dose

NICE recommends a 5-day course of high-dose antibiotics [NICE, 2017]. The GDG not that 'antibiotics did not significantly increase the proportion of adults with cure or improvement at 3 to 5 days follow-up compared with placebo (very low quality evidence). At longer durations of follow-up (approximately 7 to 15 days), there was a statistically significant difference in effectiveness for antibiotics compared with placebo, although the clinical difference in cure, improvement or clinical failure is small (moderate quality evidence). This benefit was not maintained in the longer term (approximately 16 to 60 days follow-up). Where statistically significant benefits were seen for antibiotics compared with placebo, the NNT ranged between 7 and 21 depending on the outcomes considered, with little effect on the duration of illness. This was based on evidence from 3 systematic reviews and meta-analyses of RCTs [Ahovuo-Saloranta, 2014; Falagas et al, 2008; Rosenfeld et al, 2007].


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Prognosis

NICE estimate that the average duration of acute sinusitis is 2.5 weeks [NICE, 2008b]. A systematic review analysed the placebo arms of several randomized controlled trials (RCTs), and found that, after 7–15 days, 73% of people taking placebo experienced some improvement in their symptoms, and 30% had complete recovery [Rosenfeld et al, 2007].

Analgesia

The effectiveness of paracetamol or ibuprofen in the symptomatic relief of the common cold and influenza has been confirmed by a Cochrane review of nine RCTs (n = 1069) which investigated the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of symptoms associated with the common cold, that concluded that NSAIDs were effective [Kim et al, 2013]. It is reasonable to extrapolate these data to the management of sinusitis, which has similar symptoms and causative pathogens [ICSI, 2013].

Intranasal corticosteroids

There is evidence from RCTs that intranasal corticosteroids are effective at relieving symptoms of acute sinusitis. However, they are not routinely recommended, because the clinical benefits are small and take several days to develop [Zalmanovici and Yaphe, 2009; Fokkens et al, 2012; Keith et al, 2012]. NICE recommends that they are considered in people (adults and children over the age of 12) with more prolonged or severe symptoms, (more than 10 days), when their modest effectiveness may be considered beneficial [NICE, 2017].

Scenario: Chronic sinusitis

Age from 3 months onwards

Management

Arrange admission if sinusitis is associated with a severe systemic infection, or a serious complication including:

o Orbital involvement — indicated by peri-orbital oedema or cellulitis, a displaced globe, double vision, ophthalmoplegia, or reduced visual acuity.

o Intracranial involvement — indicated by severe frontal headache, swelling over the frontal bone, symptoms or signs of meningitis, or focal neurological signs.

Inform the person of the natural course of chronic sinusitis, and that it may last several months, but does not usually require referral.

If the person has an associated disorder, such as allergic rhinitis, asthma, or dental infection advise them that good control of these is also likely to benefit their sinusitis symptoms.

Advise the person to:

o Practise good dental hygiene to reduce the risk of dental infection (which can be associated with chronic sinusitis).

o Stop smoking (and avoid passive smoking), where applicable.

o Avoid underwater diving if there are prominent symptoms.

Consider a course of intranasal corticosteroids for up to 3 months, especially if there is suspicion of an allergic cause (such as concomitant allergic rhinitis).

o Chronic sinusitis with nasal polyps should be treated in the same way as chronic sinusitis without polyps, although polyps causing severe obstruction may require referral for surgery.

Consider nasal irrigation with saline solution to relieve congestion and nasal discharge.

Seek specialist advice before prescribing long-term antibiotics, as the evidence for this approach is limited.

If the person suffers from recurrent acute episodes (acute exacerbations of chronic sinusitis):

o Recommend measures to relieve symptoms:

Paracetamol or ibuprofen — to reduce pain and fever.

Occasional use of an intranasal decongestant (for a maximum of 1 week, in adults only) — can help if nasal congestion is problematic. Oral decongestants, commonly found in combination products with an analgesic, are generally not recommended for sinusitis.










https://cks.nice.org.uk/allergic-rhinitis

https://cks.nice.org.uk/asthma


Applying warm (not hot) face packs — may provide localized relief.

o Steam inhalation is not recommended (due to the danger of burns), and the benefits of complementary and alternative medicine have not been proven.

o Consider whether a short-course of an antibiotic is appropriate (see Management of acute sinusitis).

Consider routine referral to an Ear, Nose, and Throat (ENT) specialist if the person has:

o Frequent recurrent episodes of acute sinusitis which are troublesome (such as more than three episodes requiring antibiotics in a year).

o Unremitting or progressive facial pain (but refer urgently if a tumour is suspected).

o Nasal polyps which are causing significant nasal obstruction.

o Had a trial of intranasal corticosteroids for 3 months which was ineffective.


Recommendations for information and advice are largely based on expert opinion and observational studies, rather than controlled trials. Treatment recommendations are consistent with the European position paper on rhinosinusitis and nasal polyps [Fokkens et al, 2012], and reflect historical UK practice for the treatment of chronic sinusitis.

Giving information about prognosis

The natural course of chronic sinusitis is poorly documented, but persistent symptoms are likely to last months or longer without appropriate management (intranasal corticosteroids or referral for secondary care options). However, it is widely believed that good control of predisposing factors, such as allergic rhinitis and asthma, will benefit sinusitis symptoms [Blomgren et al, 2005].

Giving advice on dental hygiene, smoking, and diving

Dental infection can be associated with chronic sinusitis [Fokkens et al, 2012], so dental hygiene should be encouraged.

Although there is no strong evidence that smoking causes chronic sinusitis, there is a hypothetical risk that tobacco smoke may exacerbate chronic sinusitis symptoms, particularly in people with allergies [Benninger, 1999].

Underwater diving is not recommended because there is a risk of sinus barotrauma (tissue injury resulting from pressure differences). Potential complications of barotrauma include cerebral empyema, pneumocephalus, blindness, and cranial nerve palsies [Parell and Becker, 2000].

Advising on self-care measures for acute episodes

Recommendations for symptomatic relief of acute symptoms are consistent with those made by the Institute for Clinical Systems Improvement [ICSI, 2013]. For further information, see Basis for management of acute sinusitis.

Prescribing intranasal corticosteroids for chronic sinusitis

Intranasal corticosteroids are recommended for the treatment of chronic sinusitis both with and without nasal polyps in the European Position Paper on Rhinosinusitis and Nasal Polyps 2012 [Fokkens et al, 2012], in combination with nasal irrigation.

o The anti-inflammatory properties of corticosteroids are well documented in other conditions, and they have been used historically to treat chronic sinusitis. There is also evidence from placebo-controlled trials to support the use of intranasal corticosteroids in people with chronic sinusitis both with, and without co-existing nasal polyps.

o Intranasal corticosteroids are likely to be well tolerated, with minimal adverse effects even after prolonged use. Inhaled corticosteroids, used by many people with asthma, are more likely to cause systemic adverse effects than intranasal corticosteroids.

Nasal irrigation

Irrigation of the nose with saline solution is recommended based on expert opinion in the European Position Paper on Rhinosinusitis and Nasal Polyps 2012 [Fokkens et al, 2012], and on evidence from a Cochrane review that it is of benefit at relieving symptoms of chronic sinusitis [Harvey et al, 2007].

https://cks.nice.org.uk/sinusitis#!scenariorecommendation

https://cks.nice.org.uk/sinusitis#!scenariorecommendation







https://cks.nice.org.uk/sinusitis#!scenariobasis

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Prolonged use of antibiotics

The evidence for prolonged use of antibiotics is lacking because of an absence of placebo-controlled trials.

o There is weak evidence that long-term treatment with a low-dose macrolide antibiotic is of benefit in chronic sinusitis in adults.

o Open-label studies have indicated that low-dose macrolides may have cure rates of 60–80% in people who are refractory to surgery, but this needs to be confirmed by further studies [Scadding, 2008].

o CKS recommends that, because of the lack of evidence of efficacy, the potential for adverse effects, and the concern of increasing bacterial resistance, specialist advice should be sought before long-term antibiotics are initiated.

Referral

Referral recommendations are based on expert opinion and are consistent with a UK guideline [Scadding, 2008] and a narrative review on the management of sinusitis [Ah-See and Evans, 2007].

o Routine referral is recommended if a trial of intranasal corticosteroids has not proved adequately effective, as this effectively represents maximal treatment in primary care. There are also limited treatment options for unremitting facial pain or frequent, severe, acute episodes of sinusitis in primary care. Options that are available in secondary care include:

Endoscopic surgery to drain sinuses and restore normal mucociliary function [Khalil and Nunez, 2006].

Removal of nasal polyps.

Surgery to correct nasal septum deviation and other nasal abnormalities (such as turbinate diathermy or reduction).

Initiation of other drug treatments (such as antibiotics or anti-leukotrienes) or aspirin desensitization (although this is rarely practised in the UK).

2. LEVEL N/A: EVIDENCE BASED GUIDELINES

BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007)

Abstract

This is an updated guideline for the diagnosis and management of allergic and nonallergic rhinitis, first published in 2007. It was produced by the Standards of Care Committee of the British Society of Allergy and Clinical Immunology, using accredited methods. Allergic rhinitis is common and affects 10–15% of children and 26% of adults in the UK, it affects quality of life, school and work attendance, and is a risk factor for development of asthma.

Allergic rhinitis is diagnosed by history and examination, supported by specific allergy tests. Topical nasal corticosteroids are the treatment of choice for moderate to severe disease. Combination therapy with intranasal corticosteroid plus intranasal antihistamine is more effective than either alone and provides second line treatment for those with rhinitis poorly controlled on monotherapy. Immunotherapy is highly effective when the specific allergen is the responsible driver for the symptoms. Treatment of rhinitis is associated with benefits for asthma. Non-allergic rhinitis also is a risk factor for the development of asthma and may be eosinophilic and steroid-responsive or neurogenic and noninflammatory.

Non-allergic rhinitis may be a presenting complaint for systemic disorders such as granulomatous or eosinophilic polyangiitis, and sarcoidoisis. Infective rhinitis can be caused by viruses, and less commonly by bacteria, fungi and protozoa.









3. LEVEL N/A: EVIDENCE BASED GUIDELINES INCLUDING CLINICAL OPINIONS Royal College of Surgeons / ENT UK Commissioning Guide 2016: Chronic Rhinosinusitis

Introduction

Rhinosinusitis is defined as inflammation of the nose and paranasal sinuses. In acute rhinosinusitis, there is complete resolution of symptoms within 12 weeks of onset; persistence of symptoms for more than 12 weeks is categorised as chronic rhinosinusitis. Acute rhinosinusitis usually has an infective aetiology. The aetiology of chronic rhinosinusitis is largely unknown but is likely to be multifactorial, with inflammation, infection and obstruction of sinus ventilation playing a part.

Chronic rhinosinusitis is a highly prevalent condition affecting 10% of the UK adult population. It is associated with significant reduction of quality of life, high health-care utilisation and significant absenteeism/presenteeism.

Diagnosis is made by the presence of two or more persistent symptoms for at least 12 weeks, one of which should be nasal obstruction and/or nasal discharge, and/or facial pain/pressure or anosmia

Chronic rhinosinusitis is sub-categorised by the presence or absence of nasal polyps (CRSwNP or CRSsNP respectively)

Treatment entails a trial of maximum medical therapy, with surgery reserved for recalcitrant cases, after the diagnosis is confirmed by radiology and after an appropriate trial of treatment. Current evidence suggest that the benefits of surgery are greatest in patients undergoing surgery at an early stage in their disease; therefore once medical therapy has been deemed to have failed there should be no further delay in referral (2). Patients undergoing surgery within 12 months of onset of symptoms that fail to respond to maximum medical therapy, achieve significantly better measured outcomes in terms on improvements in SNOT-22 than those undergoing surgery at a later stage. Health care utilisation is significantly lower in first 2 years following surgery in patients undergoing surgical intervention compared with those having surgery at a later stage.

There is over 8 fold variation in procedure rates for sinus surgery per 100,000 population by CCG across England. In patients with CRSwNP nearly 50% of patients undergoing surgery report having received more than one operation, with a mean number of 3.3 procedures per patient (range 2–30).

1.1 Primary Care

Primary care assessment

Take a history documenting the symptoms included in the diagnostic criteria below with 2 or more persistent symptoms for at least 12 weeks, one of which should be nasal obstruction and/or discharge and/or must include: facial pain/pressure or anosmia

Assessment of severity of symptoms into mild or moderate/severe. This can be facilitated by using a 10cm Visual Analogue Scale (VAS) to categorise into mild (VAS 0 – 3) or moderate/severe (VAS >3)3

Examination of anterior nasal cavity, using headlight or otoscope

o Any unilateral findings should raise suspicion of neoplasia

o Look for visible nasal polyps (consider turbinate hypertrophy in differential diagnosis)

Consider diagnosis of allergic rhinitis in patients (especially those with family history of atopy) with associated epiphora, itching, sneezing in addition to rhinorrhoea – manage according to ARIA guidelines, non-allergic rhinitis (congestion and clear rhinorrhoea), drug-induced rhinitis, structural deformity and other aetiologies (see BSACI guideline)

Assess for lower airway symptoms and control of asthma

Consider alternate diagnosis in presence of unilateral symptoms, cacosmia, crusting, epistaxis, serosanguinous or blood-stained discharge, orbital symptoms (diplopia, reduced visual acuity, globe displacement, peri-orbital oedema) or neurological symptoms (severe frontal headache, signs of symptoms of meningism, neurological signs) – consider urgent/ 2WW referral in these cases

There is no role for plain X-ray in assessment of CRS (plain X-ray, despite low cost and availability, has limited usefulness due to underestimation of bony and soft tissue sinus pathology).1 CT imaging is usually reserved for those who fail medical therapy as an aid to surgical management or have complicated infection/more serious conditions and should not be used routinely in primary care.


Offer all patients

Saline irrigation: commercially available positive pressure squeeze bottles or irrigation jugs (Netti pots) available to aid douching. High volume irrigation more effective than saline sprays (Appendix 1)

Intranasal corticosteroids (INCS): advise on correct application technique. Bioavailability varies between INCS – negligible with mometasone and fluticasone. It is essential to explain correct technique (see Appendix 1) and the need for compliance

Informed choice over treatment options is essential; patients should be provided with written information on rhinosinusitis (e.g. NHS Choices or equivalent) and actively engaged in treatment decisions

In isolated cases of purulent nasal discharge it is reasonable to prescribe a single course of antibiotics. We do not recommend repeated use of antibiotics for CRS in primary care, due to limited evidence of efficacy in unselected groups, low specificity of symptomatic diagnosis without endoscopy or imaging and risks of increasing antibiotic resistance. In particular, use of prolonged courses of macrolide antibiotics is not recommended in primary care, due to the risk of cardiac toxicity and limited evidence of benefit found only in selected CRS patient groups.

If bilateral large nasal polyps visible on anterior rhinoscopy:

Consider trial of oral prednisolone (0.5mg/kg for 5 – 10 days) followed by topical drops (fluticasone propionate 400mcg bd or beclamethasone tds) applied in the head upside down position, review after 4 weeks of treatment and refer if no improvement

If symptomatically controlled, prescribe maintenance of mometasone spray (2 squirts, each side BD). Beclamethasone drops may be prescribed for a maximum of 4 months in a 12 month period and systemic steroids given 6 monthly. Consider referral if requiring rescue medication more frequently

Reassess symptom control after 3 months of treatment with INCS and saline irrigation

For mild symptoms (VAS 0 -3) – continue with medical treatment as outlined above, emphasise need for compliance

For persistent moderate /severe symptoms at 3 months:

Assess treatment compliance and technique

Refer to specialist community or secondary care provider for nasal endoscopy and further investigation if persistent symptoms of CRS despite compliance with medical therapy

A recent study shows that 34% of patients fail medical management within 3 months of treatment. Disease specific QOL then stagnates or worsens until crossover into surgical treatment. This supports referral at 3 months, as non-responders are unlikely to respond at a later stage and will suffer deterioration in symptoms

Avoid repeated courses of antibiotics and unnecessary delay in referral

Confirmation of diagnosis by supported findings on either endoscopy or CT imaging is recommended for both EPOS and AAO-HNS definitions of CRS, as symptoms alone have a sensitivity of 89% but a specificity of only 12%, PPV of 49% and NPV of 54%. Therefore, we are unable to recommend escalation of care pathway without either endoscopy or CT, particularly as this would entail prolonged courses of antibiotics in a significant number of patients unlikely to benefit from such treatment, in the face of increasing antibiotic resistance

Either a Community Specialist or Secondary Care Specialist may perform endoscopic examination

CT imaging is normally reserved for patients selected for surgical management in order to minimize risk from exposure to ionizing radiation, and therefore not recommended for use in primary care or at this stage of the treatment pathway

1.2 Secondary care

Assessment (see above) and consider diagnosis and treatment of co-morbidity – Allergy, ASA triad, systemic conditions (vasculitides, eosinophilic granulomatosis with polyangiitis, sarcoidosis), immune deficiency etc.

Endoscopy – nasal purulence, presence of polyps or oedema in middle meatus supportive of diagnosis of CRS

Consider nasal culture – endoscopically guided middle meatal culture


Disease-specific Patient Reported Outcome Measure to assess symptom severity and response to treatment – 22 item Sinonasal Outcome Test (SNOT-22)

Consider CT when neoplasia or complications of CRS suggested (presence of orbital or neurological signs as above). Up to 40% of patients with symptoms of CRS and normal endoscopy have radiological evidence of CRS16 and CT is therefore recommended if the diagnosis remains uncertain and endoscopy is not supportive

For CRSwNP, and moderate/severe symptoms (VAS>3, SNOT-22>20)

Continue nasal saline irrigation

Short course oral steroids (0.5mg/kg 5 - 10 days)

Consider topical drops (fluticasone propionate 400mcg bd or beclamethasone tds) or continue intranasal corticosteroid spray

Consider doxycycline (100mg od 3 weeks)

Review after 3 months for moderate disease, 1 month for severe disease

For CRSsNP, and moderate/severe symptoms (VAS>3, SNOT-22>20)

Continue nasal saline irrigation

Continue intranasal corticosteroid spray

Consider long term macrolide antibiotics (most likely to be effective when IgE levels NOT elevated). Do not use macrolides in patients with significant history of cardiorespiratory disease or those taking statins

Review after 3 months

For both CRSwNP and CRSsNP

Consider endoscopic sinus surgery after failure of maximum medical therapy above and persistent moderate/severe symptoms

Patients failing to respond to medical treatment are unlikely to benefit from further prolonged courses of medical treatment and benefit from ESS is greatest in those receiving ‘early’ surgery. There is little benefit in delaying surgery for patients who fail medical treatment and are fit for surgery. However, for those who respond to medical treatment, there is no need to offer surgery as outcomes have been shown to be equivalent

CT mandatory before surgery if not performed earlier in care pathway (does not need to be repeated if no intervening surgical intervention)

When LM<4 alternate diagnosis should be considered and ESS not usually indicated

ESS not indicated if no evidence of sinus disease on CT (LM=0)

Informed choice over treatment options is essential; patients should be provided with written information on rhinosinusitis (e.g. ENT-UK leaflets on rhinosinusitis and FESS or equivalent) and actively engaged in treatment decisions. This should include discussion of potential complications of surgery which include post-operative bleeding and infection, scar tissue formation, rarely CSF leak and significant orbital injuries and the potential need for revision surgery.

There is insufficient evidence to inform as to the optimum extent of surgery, instrumentation to be used or post-operative packing materials

In suitable patients, endoscopic sinus surgery may be performed in an ambulatory setting

Patients should be discharged with written information regarding symptoms of post-operative complications to look out for including significant nasal bleeding, purulent discharge, clear rhinorrhoea, headaches, visual disturbances, persistent pain or general malaise

Post-operative care

Many patients are likely to require long-term medical maintenance therapy with saline irrigation and INCS. Use of INCS is shown to reduce risk of polyp recurrence and is safe for long term use.

Surgical intervention does allow enhanced delivery of medical treatment in topical forms (e.g. douching, steroids).

Follow-up after surgery should be tailored to individual patient needs in terms of duration and frequency and may be influenced by other factors such as atopy and co-morbidity. There is no significant evidence to support the use of frequent post-operative debridement of the sinus cavities


Once patients are stabilized post-op, further follow-up/maintenance of treatment can be provided in primary care

4. LEVEL N/A: EVIDENCE BASED GUIDELINES INCLUDING CLINICAL OPINIONS

BMJ Best Practice: Chronic sinusitis (Last reviewed: June 2018: Last updated: November 2017)

SUMMARY Inflammation of the paranasal sinuses lasting more than 12 weeks.

Diagnosis is initially clinical. Nasal endoscopy may show inflammation, purulent discharge, oedema, or frank polyps.

Medical treatment includes prolonged courses of antibiotics, corticosteroids (intranasal or systemic), saline irrigation, antihistamines, and leukotriene receptor antagonists.

CT is needed if initial medical treatment fails.

Functional endoscopic sinus surgery is very effective for patients unresponsive to medical treatment.

Definition: Chronic sinusitis is inflammation of the paranasal sinuses lasting more than 12 weeks. Symptoms include facial pressure, rhinorrhoea, postnasal drainage, congestion, and general malaise. Chronic sinusitis is divided into 2 groups, with and without polyps, which have slightly different treatment regimens. This monograph discusses chronic sinusitis in the absence of polyps. There is a separate monograph covering nasal polyps.

Epidemiology: There are estimated to be 25 cases of chronic sinusitis per 10,000 person-years in an average GP surgery in the UK.[1] It occurs in all ages, both genders, and all ethnic groups. In the US, it is the most common chronic illness, with almost 30 million Americans affected.[2] Prevalence seems to be increasing in women and individuals living in the southern US.[3] Loss of productivity and missed work/school are a major economic factor, with patients suffering a significant decrease in quality of life. Quality-of-life scores are worse than those of other chronic diseases such as heart failure, asthma, and COPD.[4]

Aetiology: The most difficult aspect of this disease is that it seems to be an endpoint (sinonasal inflammation) from many different causes, not a disease entity in and of itself. The main cause is thought to be anatomical obstruction of the osteomeatal complex (a common drainage pathway for several sinuses) leading to inadequate sinus drainage of mucus. Conditions that impair normal mucociliary clearance (the manner in which mucus is produced and characteristically moved out of the sinuses into the nasal cavity) are also

implicated. They can be categorised into three overlapping groups:

Genetic/physiological factors (e.g., cystic fibrosis/primary ciliary dyskinesia).

Environmental factors (e.g., smoking).

Structural factors (e.g., severe mid-septal deviations).

The underlying aetiology of inflammation has recently been questioned. Theories explaining the persistent inflammation include bacterial biofilms, mucosal response to fungal elements, or staphylococcal superantigens.[5] [6] [7] [8] Acute and chronic sinusitis differ in their growth of organisms. In a series of 94 endoscopically guided ethmoid sinus cultures from 50 adults with chronic sinusitis, the recovered organisms included Staphylococcus aureus (50%), gram-negative rods (20%), Haemophilus influenzae (4%), group A streptococcus (4%), Streptococcus pneumoniae (2%), and Corynebacterium diphtheriae (1%).[9] Studies have shown a higher incidence of anaerobic and polymicrobial infections in patients with chronic sinusitis compared with those with acute disease.[10]

Pathophysiology: Osteomeatal complex (OMC) obstruction is thought to be the central issue in most cases. The current theory is that underlying factors (e.g., allergy, viral infections, or air pollutants) induce local inflammation in sinonasal mucosa causing mucosal surface swelling in the narrow OMC channels. This causes sinus outflow tract obstruction and impairs mucus clearance by respiratory cilia. Sinus secretions pool, thicken, and become overgrown by micro-organisms. The exact role of micro-organisms in the chronic inflammation remains controversial. Immunodeficient patients may develop this condition from persistent infections. Anatomical abnormalities blocking the OMC (e.g., septal deviation, concha bullosa, abnormal bony cells, foreign bodies, craniofacial abnormalities) and scarring/trauma may play a role.


Secondary prevention: Prevention mainly entails avoidance of acute exacerbations through maximal treatment. Many patients also benefit from nasal saline irrigations 2 to 3 times per day to prevent secretory stasis. Maintenance therapy with other topical medications, such as nasal corticosteroid spray in polypoid disease, may be required. Managing other risk factors including allergic rhinitis and smoking is beneficial.

References

1. McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice: fourth national studym1991-1992. Office of Population Censuses and Surveys, series MB5 no 3. London, UK: HMSO; 1995.

2. Pleis JR, Lethbridge-Cejku M. Summary health statistics for U.S. adults: National health interview survey, 2005. Vital Health Stat 10. 2006;(232):1-163.

3. Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004;193:3-5

4. Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995;113:104-109.

5. Wright ED, Frenkiel S. Infectious adult rhinosinusitis: etiology, diagnosis, and management principles. J Otolaryngol. 2005;34(suppl 1):S7-S13.

6. Palmer J. Bacterial biofilms in chronic rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2006;196:35-39.

7. Ponikau JU, Sherris DA. The role of airborne mold in chronic rhinosinusitis. J Allergy Clin Immunol.2006;118:762-763.

8. Bachert C, Gevaert P, Zhang N, et al. Role of staphylococcal superantigens in airway disease. Chem Immunol Allergy. 2007;93:214-236.

9. Doyle PW, Woodham JD. Evaluation of the microbiology of chronic ethmoid sinusitis. J Clin Microbiol.1991;29:2396.

10. Shapiro ED, Milmoe GJ, Wald ER, et al. Bacteriology of the maxillary sinuses in patients with cystic fibrosis. J Infect Dis. 1982;146:589. t

11. Sakakura Y, Majima Y, Harada T, et al. Nasal mucociliary transport of chronic sinusitis in children. Arch Otolaryngol Head Neck Surg. 1992;118:1234-1237.

12. Benninger MS, Ferguson BJ, Hadley JA, et al. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003;129(3 suppl):S1-S32.

13. Lane AP, Pine HS, Pillsbury HC 3rd. Allergy testing and immunotherapy in an academic

otolaryngology practice: a 20-year review. Otolaryngol Head Neck Surg. 2001;124:9-15.

14. Weldon DR. What drives the inflammatory response in rhinosinusitis. Allergy Asthma Proc.2006;27:441-446.

15. Chee L, Graham SM, Carothers DG, et al. Immune dysfunction in refractory sinusitis in a tertiary care setting. Laryngoscope. 2001;111:233-235.

16. Briggs RD, Wright ST, Cordes S, et al. Smoking in chronic rhinosinusitis: a predictor of poor long term outcome after endoscopic sinus surgery. Laryngocope. 2004;114:126-128.

17. Lanza DC, Kennedy DW. Adult rhinosinusitis defined. Otolaryngol Head Neck Surg. 1997;117:S1-S7.

18. Thomas M, Yawn BP, Price D, et al; European Position Paper on Rhinosinusitis and Nasal Polyps Group. EPOS primary care guidelines: European position paper on the primary care diagnosis and management of rhinosinusitis and nasal polyps 2007 - a summary. Prim Care Respir J. 2008;17:79-89.

19. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(suppl 2):S1-S39.

20. Slavin RG, Spector SL, Bernstein IL, et al. The diagnosis and management of sinusitis: a practice parameter update. J Allergy Clin Immunol. 2005;116(suppl 6):S13-S47.

21. Bhattacharyya N, Fried MP. The accuracy of computed tomography in the diagnosis of chronic rhinosinusitis. Laryngoscope. 2003;113:125-129.

22. American College of Radiology. ACR appropriateness criteria: sinonasal disease. 2012. http:// www.acr.org (last accessed 27 September 2017).


23. Kuhn, JP. Imaging of the paranasal sinuses: current status. J Allergy Clin Immunol. 1986;77:6-8.

24. Araujo E, Palombini BC, Cantarelli V, et al. Microbiology of middle meatus in chronic rhinosinusitis. Am J Rhinol. 2003;17:9-15.

25. Dubin MG, Ebert CS, Coffey CS, et al. Concordance of middle meatal swab and maxillary sinus aspirate in acute and chronic sinusitis: a meta-analysis. Am J Rhinol. 2005;19:462-470.

26. Soler ZM, Oyer SL, Kern RC, et al. Antimicrobials and chronic rhinosinusitis with or without polyposis in adults: an evidenced-based review with recommendations. Int Forum Allergy Rhinol. 2013;3:31-47.

27. US Food and Drug Administration. Fluoroquinolone antibacterial drugs: drug safety communication - FDA advises restricting use for certain uncomplicated infections. May 2016. http://www.fda.gov (last accessed 27 September 2017).

28. Mösges R, Heubach CP. What is the evidence for non-antibiotic drug therapy of rhinosinusitis? Laryngorhinootologie. 2011;90:740-746.

29. Chong LY, Head K, Hopkins C, et al. Intranasal steroids versus placebo or no intervention for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016;(4):CD011996.

30. Chong LY, Head K, Hopkins C, et al. Different types of intranasal steroids for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016;(4):CD011993.

31. Wang C, Lou H, Wang X, et al. Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2015;135:922-929.

32. Rudmik L, Soler ZM. Medical therapies for adult chronic sinusitis: a systematic review. JAMA.2015;314:926-939.

33. Chong LY, Head K, Hopkins C, et al. Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016;(4):CD011995.

34. Steinke JW, Borish L. Leukotriene receptors in rhinitis and sinusitis. Curr Allergy Asthma Rep. 2004;4:217-223.

35. Sindwani R, Metson R. Image-guided frontal sinus surgery. Otolaryngol Clin North Am.

2005;38:461-471.

36. Smith TL, Stewart MG, Orlandi RR, et al. Indications for image-guided sinus surgery: the current evidence. Am J Rhinol. 2007;21:80-83.

37. Mehta U, Huber TC, Sindwani R. Patient expectations and recovery following endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2006;134:483-487.

38. Chester AC, Antisdel JL, Sindwani R. Symptom-specific outcomes of endoscopic sinus surgery: a systematic review. Otolaryngol Head Neck Surg. 2009;140:633-639.

39. Chester AC, Sindwani R, Smith TL, et al. Systematic review of change in bodily pain after sinus surgery. Otolaryngol Head Neck Surg. 2008;139:759-765.

40. Chester AC, Sindwani R, Smith TL, et al. Fatigue improvement following endoscopic sinus surgery: asystematic review and meta-analysis. Laryngoscope. 2008;118:730-739.

41. Ebbens FA, Georgalas C, Luiten S, et al. The effect of topical amphotericin B on inflammatory markers in patients with chronic rhinosinusitis: a multicenter randomized controlled study. Laryngoscope.2009;119:401-408.

42. Lim M, Citardi MJ, Leong JL.Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008;22:381-389.

43. National Institute for Health and Care Excellence. Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. September 2008. http://www.nice.org.uk (last accessed 27 September 2017).

44. Taghi AS, Khalil SS, Mace AD, et al. Balloon sinuplasty: balloon-catheter dilation of paranasal sinus ostia for chronic rhinosinusitis. Expert Rev Med Devices. 2009;6:377-382

45. Batra PS, Ryan MW, Sindwani R, et al. Ballon catheter technology in rhinology: reviewing the evidence. Laryngoscope. 2011;121:226-232.

46. Chandler JR, Langenbrunner DJ, Stevens ER. The pathogenesis of orbital complications in acute sinusitis. Laryngoscope. 1970;80:1414-1428.

47. Parell GJ, Becker GD. Neurological consequences of scuba diving with chronic sinusitis.

Laryngoscope. 2000;110:1358-1360


Appendix 2 – Diagnostic and Procedure Codes



GM065 – Rhinosinusitis / Rhinitis / Sinusitis

OPCS-4 Procedure Codes

Ligation of maxillary artery using sublabial approach E121

Drainage of maxillary antrum using sublabial approach E122

Irrigation of maxillary antrum using sublabial approach E123

Transantral neurectomy of vidian nerve using sublabial approach E124

Other specified operations on maxillary antrum using sublabial approach E128

Unspecified operations on maxillary antrum using sublabial approach E129

Drainage of maxillary antrum NEC E131

Excision of lesion of maxillary antrum E132

Intranasal antrostomy E133

Biopsy of lesion of maxillary antrum E134

Closure of fistula between maxillary antrum and mouth E135

Puncture of maxillary antrum E136

Neurectomy of vidian nerve NEC E137

Other specified other operations on maxillary antrum E138

Unspecified other operations on maxillary antrum E139

External frontoethmoidectomy E141

Intranasal ethmoidectomy E142

External ethmoidectomy E143

Transantral ethmoidectomy E144

Bone flap to frontal sinus E145

Trephine of frontal sinus E146

Median drainage of frontal sinus E147

Other specified operations on frontal sinus E148

Unspecified operations on frontal sinus E149

Drainage of sphenoid sinus E151


Puncture of sphenoid sinus E152

Repair of sphenoidal sinus E153

Excision of lesion of sphenoid sinus E154

Other specified operations on sphenoid sinus E158

Unspecified operations on sphenoid sinus E159

Frontal sinus osteoplasty E161

Drainage of frontal sinus NEC E162

Other specified other operations on frontal sinus E168

Unspecified other operations on frontal sinus E169

Excision of nasal sinus NEC E171

Excision of lesion of nasal sinus NEC E172

Biopsy of lesion of nasal sinus NEC E173

Lateral rhinotomy into nasal sinus NEC E174

Other specified operations on unspecified nasal sinus E178

Unspecified operations on unspecified nasal sinus E179

Functional endoscopic sinus surgery (secondary to another code) Y761

Functional endoscopic nasal surgery (secondary to another code) Y762

Diagnostic endoscopic examination of nasal cavity and biopsy of lesion of nasal cavity E651

Other specified diagnostic endoscopic examination of nasal cavity E658

Unspecified diagnostic endoscopic examination of nasal cavity E659

With the following ICD-10 diagnosis codes:

Vasomotor rhinitis J300

Allergic rhinitis due to pollen J301

Other seasonal allergic rhinitis J302

Other allergic rhinitis J303

Allergic rhinitis, unspecified J304

Chronic rhinitis J310

Chronic maxillary sinusitis J320

Chronic frontal sinusitis J321

Chronic ethmoidal sinusitis J322

Chronic sphenoidal sinusitis J323


Chronic pansinusitis J324

Other chronic sinusitis J328

Chronic sinusitis, unspecified J329

ICD-10 diagnosis codes (Exceptions):

Malignant neoplasm of nasal cavity C300

Malignant neoplasm of maxillary sinus C310

Malignant neoplasm of ethmoidal sinus C311

Malignant neoplasm of frontal sinus C312

Malignant neoplasm of sphenoidal sinus C313

Malignant neoplasm of overlapping lesion of accessory sinuses C318

Malignant neoplasm of accessory sinus, unspecified C319

Sarcoidosis of lung D860

Sarcoidosis of lymph nodes D861

Sarcoidosis of lung with sarcoidosis of lymph nodes D862

Sarcoidosis of skin D863

Sarcoidosis of other and combined sites D868

Sarcoidosis, unspecified D869

Epiphora H042

Acute inflammation of orbit H050

Exophthalmic conditions H052

Third [oculomotor] nerve palsy H490

Fourth [trochlear] nerve palsy H491

Sixth [abducent] nerve palsy H492

Total (external) ophthalmoplegia H493

Progressive external ophthalmoplegia H494

Other paralytic strabismus H498

Paralytic strabismus, unspecified H499

Diplopia H532

Blindness, binocular H540

Severe visual impairment, binocular H541

Moderate visual impairment, binocular H542


Mild or no visual impairment, binocular H543

Blindness, monocular H544

Severe visual impairment, monocular H545

Moderate visual impairment, monocular H546

Unspecified visual impairment (binocular) H549

Acute nasopharyngitis [common cold] J00X

Acute maxillary sinusitis J010

Acute frontal sinusitis J011

Acute ethmoidal sinusitis J012

Acute sphenoidal sinusitis J013

Acute pansinusitis J014

Other acute sinusitis J018

Acute sinusitis, unspecified J019

Polyp of nasal cavity J330

Polypoid sinus degeneration J331

Other polyp of sinus J338

Nasal polyp, unspecified J339

Deviated nasal septum J342

Other specified disorders of nose and nasal sinuses J348

Polyarteritis nodosa M300

Epistaxis R040

Anosmia R430

Headache R51X


Appendix 3 – Version History


The latest version of this policy can be found here [To add link when final policy approved]



0.2 18/07/2018 The GM EUR Steering Group requested the following amendments:

Policy Exclusions: ‘NOTE: the higher incidence of nasopharyngeal cancer in individuals of South East Asian origin5’ added.

Policy Inclusion Criteria: o Link added to RCS / ENT UK Commissioning Guidelines at end of ‘Prior

to Referral’ and ‘In secondary care’ sections. o Recommended funding mechanism agreed for Monitored Approval.

References: ‘Chin J Cancer. 2011 Feb; 30(2): 114–119. The prevalence and prevention of nasopharyngeal carcinoma in China Su-Mei Cao et al.’ added

The GM EUR Steering Group agreed that following the above changes being made the policy could go out for a period of clinical engagement.

0.3 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.4 21/11/2018 GM EUR Steering Group reviewed the Clinical Engagement feedback and agreed the following amendments to the policy:

Commissioning Statement o Best practice guidelines section added o ‘Other referrals’ section added o First bullet point under ‘Prior to referral’ and the ‘Primary care

assessment sub-heading’ corrected, as first part of it should of been before the bullet point.

o ‘Patients management prior to referral’ section added and the last paragraph from ‘Referral to secondary care’ moved to this section also.

o The word ‘frequent’ in paragraph five the ‘In secondary care’ section made bold and underlined

Subject to the above amendments being made the GM EUR Steering Group approved the policy to go through the CCG governance process.



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4013340/

https://www.ncbi.nlm.nih.gov/pubmed/?term=Cao%20SM%5BAuthor%5D&cauthor=true&cauthor_uid=21272443



Dilatation and curettage (D&C); and Hysterectomy for heavy menstrual bleeding GM Ref: GM072 Version: 0.4 (12 September 2019)

DandC and Hysterectomy for HMB Policy v0.4 DRAFT Page 2 of 22


Dilatation and curettage (D&C); and Hysterectomy for heavy menstrual bleeding


Investigations

Hysteroscopy (outpatient, day case and inpatient), including see and treat services

Pelvic ultrasound

Transvaginal ultrasound

Dilatation to enable hysteroscopy Treatments

Levonorgestrel-releasing intrauterine system

Medical and hormonal treatments

Endometrial ablation

Myomectomy

Dilatation and curettage for evacuation of retained products of conception Treatment / procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).


Clinicians are expected to diagnose, refer and manage patients in line with NICE NG88: Heavy menstrual bleeding: assessment and management (see Appendix 1 for a summary). Diagnostic dilatation and curettage (D&C) for heavy menstrual bleeding

This policy covers both diagnostic D&C and D&C used solely to treat heavy menstrual bleeding. These procedures are not commissioned. Please refer for hysteroscopy or ultrasound investigations instead.

Funding Mechanism


Hysterectomy for heavy menstrual bleeding (HMB)

Commissioned only as a second-line or subsequent treatment. Hysterectomy should be considered only when ALL of the following conditions are met:

There is documented evidence that all other treatment options have failed, are contraindicated or have been offered and declined by the woman.

o For women with no identified pathology, fibroids less than 3 cm in diameter, or suspected or diagnosed adenomyosis, treatments include:

LNG-IUS (first-line)

tranexamic acid

http://nice.org.uk/guidance/ng88

http://nice.org.uk/guidance/ng88


NSAIDs (non-steroidal anti-inflammatory drugs)

combined hormonal contraception

cyclical oral progestogens

second generation endometrial ablation

o For women with fibroids of 3 cm or more in diameter, treatments include:

tranexamic acid

NSAIDs

ulipristal acetate

LNG-IUS

combined hormonal contraception


uterine artery embolisation

myomectomy

there is a wish for amenorrhea (no periods);

the woman (who has been fully informed) requests it;

the woman no longer wishes to retain her uterus and fertility.

Funding Mechanism

Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence and include a documented discussion with the patient about all treatment options (NICE QS47).




Fitness for Surgery


Best Practice Guidelines

All providers are expected to follow best practice guidelines (where available) in the management of these conditions.

Smoking and weight management

Where appropriate patients should be referred to smoking cessation and / or weight management services prior to the intervention requested.













Date of Review ......................................................................................................................................... 7

Glossary ................................................................................................................................................... 7

References ............................................................................................................................................... 8

Governance Approvals ............................................................................................................................. 8

Appendix 1 – Evidence Review ................................................................................................................ 9






Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

reducing the variation in access to treatments/procedures.





ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester.


Rationale behind the policy statement D&C

D&C should not be used for diagnosis or treatment for heavy menstrual bleeding in women because it is less clinically effective than widely available alternative diagnostic approaches and treatments. Since curettage involves taking an unguided endometrial sample from the cervix, it is an inferior investigation to hysteroscopy. Limited evidence is available on the use of therapeutic dilatation and curettage for HMB, but the one study that was identified showed that any effect was temporary5. UItrasound scans and camera tests with sampling of the lining of the womb (hysteroscopy and biopsy) should be used to investigate heavy periods. Medication and intrauterine systems (IUS) should be used to treat heavy periods. D&C is a Category 1 procedure under NHS England’s Evidence Based Interventions policy: Interventions which should not be routinely commissioned or performed. Hysterectomy

Based on NICE guidelines, hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding. It is important that healthcare professionals understand what matters most to each woman and support her personal priorities and choices. hysterectomy should be considered only when ALL of the following are met:

other treatment options have failed or are contradicted

there is a wish for amenorrhoea (no periods)

the woman (who has been fully informed) requests it

the woman no longer wishes to retain her uterus and fertility Hysterectomy is a Category 2 procedure under NHS England’s Evidence Based Interventions policy: Interventions which should only be routinely commissioned or performed when specific criteria are met

Treatment / Procedure Heavy menstrual bleeding (HMB, also known as menorrhagia) is excessive menstrual blood loss which interferes with the woman’s physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms D&C

Dilation (or dilatation) and curettage (D&C) refers to the dilation (widening/opening) of the cervix and surgical removal of part of the lining of the uterus and/or contents of the uterus by scraping and scooping (curettage). Hysterectomy

Hysterectomy is the surgical removal of the uterus. Hysterectomy is a major operation associated with significant complications in a minority of cases.


Epidemiology and Need HMB is a common problem, with a 12-month cumulative incidence of 25% in all menstruating women in the UK. Not every woman with HMB visits her GP. In the UK, consultation rates are 9.3 per 1000 women per year. Women with HMB symptoms that interfere with daily life are more likely to consult a doctor for HMB6. HMB has a major impact on a woman's quality of life, and it is crucial to ensure that any intervention aims to improve this rather than focusing on blood loss5.

Adherence to NICE Guidance This policy statement is fully aligned with NICE Guidance NG88: Heavy menstrual bleeding: assessment and management (2018). These policies also adhere to Evidence-Based Interventions: Consultation Document, published by NHS England, NHS Clinical Commissioners, the Academy of Medical Royal Colleges, NHS Improvement and the National Institute for Health and Care Excellence. D&C is in Category 1: Interventions which should not be routinely commissioned or performed. Hysterectomy is in Category 2: Interventions which should only be routinely commissioned or performed when specific criteria are met



Glossary

Term Meaning

Dilatation and Curettage

The dilation (widening/opening) of the cervix and surgical removal of part of the lining of the uterus and/or contents of the uterus by scraping and scooping (curettage).

Fibroids Fibroids are non-cancerous growths that develop in or around the womb (uterus).

Hysterectomy Surgical removal of the uterus (womb).

Hysteroscopy A hysteroscopy is an examination of the inside of the womb (uterus) using a hysteroscope. Hysteroscopy allows for direct visualisation of the inside of the womb. The hysteroscope is carefully passed through the vagina and cervix, and into the womb. During the procedure a biopsy may be taken for examination.

Menorrhagia Heavy menstrual bleeding (heavy periods).


References

1. GM EUR Operational Policy

2. NICE Guidance NG88: Heavy menstrual bleeding: assessment and management (2018)

3. Evidence-Based Interventions: Consultation Document, published by NHS England, NHS Clinical Commissioners, the Academy of Medical Royal Colleges, NHS Improvement and the National Institute for Health and Care Excellence (2018)

4. NICE Quality Standard QS47: Heavy menstrual bleeding (2018)

5. NICE / RCOG CG44: Heavy menstrual bleeding (2007) – Superseded

6. Marian J van den Brink et al. Incidence and treatment of heavy menstrual bleeding in general practice. Family Practice, 2017, Vol. 34, No. 6, 673–678

7. NHS England: Evidence based interventions: response to the public consultation and next steps


Name Date Approved


Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board)












Appendix 1 – Evidence Review Dilatation and curettage (D&C) and Hysterectomy for heavy menstrual bleeding

GM


Database Result

NICE Clinical Guidance

NICE NG88: Heavy Menstrual Bleeding (2018), superseded guidance CG44 (2007) published jointly with RCOG

NICE Evidence Quality Standard QS47: Heavy menstrual bleeding (2018) - not cited here as based on NG88

NICE CKS Menorrhagia Scenario: Management (last revised 2017)

RCOG Superseded guidance CG44 (2007) published jointly with NICE so not cited here

Other NHS England Evidence Based Interventions: Response to the public consultation and next steps, intervention description and criteria following public consultation

Summary of the evidence The evidence-based consensus in all of the above guidelines is that D&C is not effective as alternative diagnostic options, and is ineffective as a or treatment option for heavy menstrual bleeding, so should not be offered. The evidence-based consensus in all of the above guidelines is that hysterectomy should not be considered as a first line treatment for heavy menstrual bleeding and should only be considered when ALL of the following are met:

other treatment options have failed or are contraindicated

there is a wish for amenorrhoea (no periods)

the woman (who has been fully informed) requests it

the woman no longer wishes to retain her uterus and fertility

The evidence

Levels of evidence







1. LEVEL 1: NICE GUIDELINES

NICE NG88: Heavy menstrual bleeding: assessment and management, Published 14 March 2018

1. Recommendations

1.1 Impact of heavy menstrual bleeding (HMB) on women

1.1.1 Recognise that heavy menstrual bleeding (HMB) has a major impact on a woman's quality of life, and ensure that any intervention aims to improve this rather than focusing on blood loss. [2007]

1.2 History, physical examination and laboratory tests

History

1.2.1 Take a history from the woman that covers:

the nature of the bleeding

related symptoms, such as persistent intermenstrual bleeding, pelvic pain and/or pressure symptoms, that might suggest uterine cavity abnormality, histological abnormality, adenomyosis or fibroids

impact on her quality of life

other factors that may affect treatment options (such as comorbidities or previous treatment for HMB). [2007, amended 2018]

1.2.2 Take into account the range and natural variability in menstrual cycles and blood loss when diagnosing HMB, and discuss this variation with the woman. If the woman feels that she does not fall within the normal ranges, discuss care options. [2007]

1.2.3 If the woman has a history of HMB without other related symptoms (see recommendation 1.2.1), consider pharmacological treatment without carrying out a physical examination (unless the treatment chosen is levonorgestrel releasing intrauterine system [LNG IUS][1]). [2007, amended 2018]

Physical examination

1.2.4 If the woman has a history of HMB with other related symptoms (see

recommendation 1.2.1) offer a physical examination. [2007, amended 2018]

1.2.5 Carry out a physical examination before all investigations or LNG-IUS[1] fittings.

[2007]

Laboratory tests

1.2.6 Carry out a full blood count test for all women with HMB, in parallel with any HMB treatment offered. [2007]

1.2.7 Testing for coagulation disorders (for example, von Willebrand's disease) should be considered for women who:

have had HMB since their periods started and

have a personal or family history suggesting a coagulation disorder. [2007]

1.2.8 Do not routinely carry out a serum ferritin test for women with HMB. [2007]

1.2.9 Do not carry out female hormone testing for women with HMB. [2007]

1.2.10 Do not carry out thyroid hormone testing for women with HMB unless other signs and symptoms of thyroid disease are present. [2007]

1.3 Investigations for the cause of HMB


Before starting investigations

1.3.1 Consider starting pharmacological treatment for HMB without investigating the cause if the woman's history and/or examination suggests a low risk of fibroids, uterine cavity abnormality, histological abnormality or adenomyosis. [2018]

1.3.2 If cancer is suspected, see the NICE guideline on suspected cancer: recognition and referral. [2007]

Investigations

1.3.3 Take into account the woman's history and examination when deciding whether to offer hysteroscopy or ultrasound as the first-line investigation. [2018]

Women with suspected submucosal fifibroids, polyps or endometrial pathology

1.3.4 Offer outpatient hysteroscopy to women with HMB if their history suggests submucosal fibroids, polyps or endometrial pathology because:

they have symptoms such as persistent intermenstrual bleeding or

they have risk factors for endometrial pathology (see recommendation 1.3.10). [2018]

1.3.5 Ensure that outpatient hysteroscopy services are organised and the procedure is performed according to best practice, including:

advising women to take oral analgesia before the procedure

vaginoscopy as the standard diagnostic technique, using miniature hysteroscopes (3.5mm or smaller). [2018]

1.3.6 Ensure that hysteroscopy services are organised to enable progression to 'see-and-treat' hysteroscopy in a single setting if feasible. [2018]

1.3.7 Explain to women with HMB who are offered outpatient hysteroscopy what the procedure involves and discuss the possible alternatives. [2018]

1.3.8 If a woman declines outpatient hysteroscopy, offer hysteroscopy under general or regional anaesthesia. [2018]

1.3.9 For women who decline hysteroscopy, consider pelvic ultrasound, explaining the limitations of this technique for detecting uterine cavity causes of HMB. [2018]

1.3.10 Consider endometrial biopsy at the time of hysteroscopy for women who are at high risk of endometrial pathology, such as:

women with persistent intermenstrual or persistent irregular bleeding, and women with infrequent heavy bleeding who are obese or have polycystic ovary syndrome

women taking tamoxifen

women for whom treatment for HMB has been unsuccessful. [2007, amended 2018]

1.3.11 Obtain an endometrial sample only in the context of diagnostic hysteroscopy. Do not offer 'blind' endometrial biopsy to women with HMB. [2018]

Women with possible larger fibroids

1.3.12 Offer pelvic ultrasound to women with HMB if any of the following apply:

their uterus is palpable abdominally

history or examination suggests a pelvic mass

examination is inconclusive or difficult, for example in women who are obese. [2018]

Women with suspected adenomyosis

1.3.13 Offer transvaginal ultrasound (in preference to transabdominal ultrasound or MRI) to women with HMB who have:

significant dysmenorrhoea (period pain) or

a bulky, tender uterus on examination that suggests adenomyosis. [2018]

1.3.14 If a woman declines transvaginal ultrasound or it is not suitable for her, consider transabdominal ultrasound or MRI, explaining the limitations of these techniques. [2018]

1.3.15 Be aware that pain associated with HMB may be caused by endometriosis rather than adenomyosis (see NICE's guideline on endometriosis). [2018]


Other diagnostic tools

1.3.16 Do not use saline infusion sonography as a first-line diagnostic tool for HMB. [2007]

1.3.17 Do not use MRI as a first-line diagnostic tool for HMB. [2007]

1.3.18 Do not use dilatation and curettage alone as a diagnostic tool for HMB. [2007]

1.4 Information for women about HMB and treatments

1.4.1 Provide women with information about HMB and its management. Follow the principles in the NICE guideline on patient experience in adult NHS services in relation to communication, information and shared decision-making. [2018]

1.4.2 Provide information about all possible treatment options for HMB and discuss these with the woman (see section 1.5). Discussions should cover:

the benefits and risks of the various options

suitable treatments if she is trying to conceive

whether she wants to retain her fertility and/or her uterus. [2018]

Levonorgestrel-releasing intrauterine system (LNG-IUS)

1.4.3 Explain to women who are offered an LNG-IUS[1]:

about anticipated changes in bleeding pattern, particularly in the first few cycles and maybe lasting longer than 6 months

that it is advisable to wait for at least 6 cycles to see the benefits of the treatment. [2007]

Impact of treatments on fertility

1.4.4 Explain to women about the impact on fertility that any planned surgery or uterine artery embolisation may have, and if a potential treatment (hysterectomy or ablation) involves loss of fertility then opportunities for discussion should be made available. [2007]

1.4.5 Explain to women that uterine artery embolisation or myomectomy may potentially allow them to retain their fertility. [2007]

Endometrial ablation

1.4.6 Advise women to avoid subsequent pregnancy and use effective contraception, if needed, after endometrial ablation. [2007]

Hysterectomy

1.4.7 Have a full discussion with all women who are considering hysterectomy about the implications of surgery before a decision is made. The discussion should include:

sexual feelings

impact on fertility

bladder function

need for further treatment

treatment complications

her expectations

alternative surgery

psychological impact. [2007]

1.4.8 Inform women about the increased risk of serious complications (such as intraoperative haemorrhage or damage to other abdominal organs) associated with hysterectomy when uterine fibroids are present. [2007]

1.4.9 Inform women about the risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy. [2007]

1.5 Management of HMB

1.5.1 When agreeing treatment options for HMB with women, take into account:

the woman's preferences

any comorbidities


the presence or absence of fibroids (including size, number and location), polyps,endometrial pathology or adenomyosis

other symptoms such as pressure and pain. [2018]

Treatments for women with no identifified pathology, fifibroids less than 3 cm in

diameter, or suspected or diagnosed adenomyosis

1.5.2 Consider an LNG-IUS[1] as the first treatment for HMB in women with:

no identified pathology or

fibroids less than 3 cm in diameter, which are not causing distortion of the uterine cavity or

suspected or diagnosed adenomyosis. [2018]

1.5.3 If a woman with HMB declines an LNG-IUS or it is not suitable, consider the following pharmacological treatments:

non-hormonal:

o tranexamic acid

o NSAIDs (non-steroidal anti-inflammatory drugs)[2]

hormonal:

o combined hormonal contraception[3]

o cyclical oral progestogens. [2018]

1.5.4 Be aware that progestogen-only contraception may suppress menstruation, which could be beneficial to women with HMB. [2018]

1.5.5 If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, consider referral to specialist care for:

investigations to diagnose the cause of HMB, if needed (see section 1.3) taking into account any investigations the woman has already had and

alternative treatment choices, including:

o pharmacological options not already tried (see recommendations 1.5.2 and 1.5.3)

o surgical options:

second-generation endometrial ablation

hysterectomy. [2018]

1.5.6 For women with submucosal fibroids, consider hysteroscopic removal. [2018]

Treatments for women with fibroids of 3 cm or more in diameter

1.5.7 Consider referring women to specialist care to undertake additional investigations and discuss treatment options for fibroids of 3 cm or more in diameter. [2018]

1.5.8 If pharmacological treatment is needed while investigations and definitive treatment are being organised, offer tranexamic acid and/or NSAIDs[2]. [2007]

1.5.9 Advise women to continue using NSAIDs[2] and/or tranexamic acid for as long as they are found to be beneficial. [2007]

1.5.10 For women with fibroids of 3 cm or more in diameter, take into account the size, location and number of fibroids, and the severity of the symptoms and consider the following treatments:

pharmacological:

o non-hormonal:

tranexamic acid

NSAIDs[2]

o hormonal:

ulipristal acetate (see recommendations 1.5.11 and 1.5.12)

LNG-IUS[1]

combined hormonal contraception[3]



uterine artery embolisation

surgical:

o myomectomy

o hysterectomy. [2018, amended Nov 2018]

1.5.11 If ulipristal acetate[4] is the preferred treatment option, be aware of measures to reduce the risk of rare but serious liver injury:

discuss the relative benefits and harms of ulipristal acetate with women, including recognising the signs and symptoms of liver injury, to enable an informed decision

monitor liver function for the first 2 treatment courses, and as clinically indicated, in line with current prescribing guidance. [Nov 2018]

1.5.12 When ulipristal[4] is used for intermittent treatment in women who are not eligible for surgery, for example where the risks of surgery outweigh the benefits or where the woman declines surgical treatment:

Offer ulipristal acetate 5 mg (up to 4 courses) to women with heavy menstrual bleeding and fibroids of 3 cm or more in diameter, and a haemoglobin level of 102 g per litre or below.

Consider ulipristal acetate 5 mg (up to 4 courses) for women with heavy menstrual bleeding and fibroids of 3 cm or more in diameter, and a haemoglobin level above 102 g per litre. [Nov 2018]

1.5.13 Be aware that the effectiveness of pharmacological treatments for HMB (excluding ulipristal acetate) may be limited in women with fibroids that are substantially greater than 3 cm in diameter. [2018, amended Nov 2018]

1.5.14 Prior to scheduling of uterine artery embolisation or myomectomy, the woman's uterus and fibroid(s) should be assessed by ultrasound. If further information about fibroid position, size, number and vascularity is needed, MRI should be considered. [2007]

1.5.15 Consider second-generation endometrial ablation as a treatment option for women with HMB and fibroids of 3 cm or more in diameter who meet the criteria specified in the manufacturers' instructions. [2018]

1.5.16 If treatment is unsuccessful:

consider further investigations to reassess the cause of HMB (see section 1.3), taking into account the results of previous investigations and

offer alternative treatment with a choice of the options described in recommendation 1.5.10. [2018]

1.5.17 Pretreatment with a gonadotrophin-releasing hormone analogue[5] or ulipristal acetate before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus. [2007, amended 2018, amended Nov 2018]

Route and method of hysterectomy

1.5.18 When discussing the route of hysterectomy (laparoscopy, laparotomy or vaginal) with the woman, carry out an individual assessment and take her preferences into account. [2007, amended 2018]

1.5.19 Discuss the options of total hysterectomy (removal of the uterus and the cervix) and subtotal hysterectomy (removal of the uterus and retention of the cervix) with the woman. [2007, amended 2018]

Removal of ovaries (oophorectomy) with hysterectomy

1.5.20 Only remove ovaries with hysterectomy with the express wish and informed consent of the woman, after discussion of all associated risks and benefits. [2007, amended 2018]

Dilatation and curettage

1.5.21 Do not offer dilatation and curettage as a treatment option for HMB. [2007]

1.5.22 If dilatation is needed for non-hysteroscopic endometrial ablation:

confirm that there is no evidence of uterine perforation or false passage

use hysteroscopy before inserting the ablation device, to establish the condition of the uterus

ultrasound may be used to ensure correct uterine placement of the ablation device; if the device uses a balloon, keep this inflated during the ultrasound scan. [2007,amended 2018]


2. LEVEL N/A: NICE CLINICAL KNOWLEDGE SUMMARY NICE CKS: Menorrhagia (last revised 2017)

Scenario: Management

Treatment

Medical treatment is recommended first-line for women with menorrhagia who:

o Have no symptoms that suggest an underlying pathology.

o Are awaiting the results of investigations.

Depending on the acceptability to the woman, consider treatments in the following order:

o Levonorgestrel intrauterine system (LNG-IUS) provided long-term (at least 12 months) use is anticipated. For more information, see the section on LNG-IUS in the CKS topic on Contraception - IUS/IUD.

o Tranexamic acid, or nonsteroidal anti-inflammatory drugs (NSAIDs), or combined oral contraceptives (COCs). For more information, see the CKS topics on NSAIDs - prescribing issues and Contraception - combined hormonal methods.

When menorrhagia coexists with dysmenorrhoea, NSAIDs should be prescribed in preference to tranexamic acid.

COCs are suitable for women who do not want to, or cannot, take NSAIDs.

o Norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle, or long-acting progestogen-only injectable. For more information, see the section on progestogen-only injectables in the CKS topic on Contraception - progestogen-only methods.

If initial treatment is ineffective, a second treatment can be considered before referring to a specialist.

o Consider a trial of one form of non-hormonal treatment and one form of hormonal treatment.

o Use of NSAIDs and/or tranexamic acid should be stopped if symptoms are not improved within 3 menstrual cycles.

o Consider combining treatments if appropriate.

Tranexamic can be combined with a nonsteroidal anti-inflammatory drug (NSAID) if menstrual bleeding and dysmenorrhoea are problematic.

An NSAID may be used with a COC, especially if dysmenorrhoea is problematic.

Do not combine tranexamic acid with a COC or LNG-IUS.

There are no recommendations on whether an NSAID may be combined with LNG-IUS. They are commonly prescribed in combination in practice.

If combined medication is being considered because bleeding or pain is very severe, reconsider the cause, and consider referral.

3. LEVEL: N/A

NHS England Evidence Based Interventions: Response to the public consultation and next steps, intervention description and criteria following public consultation

Dilatation and curettage (D&C) for heavy menstrual bleeding in women

Updated description of the intervention

NICE guidelines recommend that D&C is not offered as a diagnostic or treatment option for heavy menstrual bleeding, as there is very little evidence to suggest that it works to investigate or treat heavy periods.

Ultrasound scans and camera tests, with sampling of the lining of the womb (hysteroscopy and biopsy), can be used to investigate heavy periods. Medication and intrauterine systems (IUS), as well as weight loss (if appropriate) can treat heavy periods.

Updated clinical criteria

Summary of intervention: Dilation and curettage (D&C) is a minor surgical procedure where the opening of the womb (cervix) is widened (dilatation) and the lining of the womb is scraped out (curettage).


Number of CCG interventions in 2017/18: 236

Recommendation: D&C should not be used for diagnosis or treatment for heavy menstrual bleeding in women because it is clinically ineffective.

UIltrasound scans and camera tests with sampling of the lining of the womb (hysteroscopy and biopsy) can be used to investigate heavy periods. Medication and intrauterine systems (IUS) can be used to treat heavy periods. For further information, please see:


https://www.nhs.uk/conditions/hysteroscopy/#alternatives-to-hysteroscopy

Rationale for Recommendation: NICE guidelines recommend that D&C is not offered as a treatment option for heavy menstrual bleeding. There is very little evidence to suggest that D&C works to treat heavy periods and the one study identified by NICE showed the effects were only temporary. D&C should not be used to investigate heavy menstrual bleeding as hysteroscopy and biopsy work better. Complications following D&C are rare but include uterine perforation, infection, adhesions (scar tissue) inside the uterus and damage to the cervix. Hysterectomy for heavy menstrual bleeding

Updated description of the intervention

NICE recommends that hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding (HMB). Heavy periods can be reduced by using medicines or intrauterine systems (IUS) or losing weight (if necessary).

Updated clinical criteria

Summary of intervention: Hysterectomy is the surgical removal of the uterus.

Number of CCG interventions in 2017/18: 27,660

Recommendation: Based on NICE guidelines [Heavy menstrual bleeding: assessment and management [NG88] Published date: March 2018], hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding.

It is important that healthcare professionals understand what matters most to each woman and support her personal priorities and choices.

Hysterectomy should be considered only when: other treatment options have failed, are contradicted; there is a wish for amenorrhoea (no periods); the woman (who has been fully informed) requests it; the woman no longer wishes to retain her uterus and fertility.

1.10.1.1.1 NICE guideline NG88 1.5 Management of HMB

1.5.1 When agreeing treatment options for HMB with women, take into account:

the woman's preferences, any comorbidities, the presence or absence of fibroids (including size, number and location), polyps, endometrial pathology or adenomyosis, other symptoms such as pressure and pain.

1.10.1.1.2 Treatments for women with no identified pathology, fibroids less than 3 cm in diameter, or suspected or diagnosed adenomyosis

1.5.2 Consider an LNG-IUS (levonorgestrel-releasing intrauterine system) as the first treatment for HMB in women with: no identified pathology or fibroids less than 3 cm in diameter, which are not causing distortion of the uterine cavity or suspected or diagnosed adenomyosis.

1.5.3 If a woman with HMB declines an LNG-IUS or it is not suitable, consider the following pharmacological treatments: non-hormonal: tranexamic acid, NSAIDs (non-steroidal anti-inflammatory drugs), hormonal: combined hormonal contraception, cyclical oral progestogens.

1.5.4 Be aware that progestogen-only contraception may suppress menstruation, which could be beneficial to women with HMB.

1.5.5 If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, consider referral to specialist care for: investigations to diagnose the cause of HMB, if needed, taking into account any investigations the woman has already had and alternative treatment choices, including:

pharmacological options not already tried (see recommendations 1.5.2 and 1.5.3),

surgical options: second-generation endometrial ablation, hysterectomy.


https://www.nhs.uk/conditions/hysteroscopy/#alternatives-to-hysteroscopy


1.5.6 For women with submucosal fibroids, consider hysteroscopic removal.

1.10.1.1.3 Treatments for women with fibroids of 3 cm or more in diameter

1.5.7 Consider referring women to specialist care to undertake additional investigations and discuss treatment options for fibroids of 3 cm or more in diameter.

1.5.8 If pharmacological treatment is needed while investigations and definitive treatment are being organised, offer tranexamic acid and/or NSAIDs.

1.5.9 Advise women to continue using NSAIDs and/or tranexamic acid for as long as they are found to be beneficial.

1.5.10 For women with fibroids of 3 cm or more in diameter, take into account the size, location and number of fibroids, and the severity of the symptoms and consider the following treatments: pharmacological: non-hormonal: tranexamic acid, NSAIDs, hormonal: LNG-IUS, combined hormonal contraception, cyclical oral progestogens, uterine artery embolization, surgical: myomectomy, hysterectomy.

1.5.12 Be aware that the effectiveness of pharmacological treatments for HMB may be limited in women with fibroids that are substantially greater than 3 cm in diameter.

1.5.13 Prior to scheduling of uterine artery embolisation or myomectomy, the woman's uterus and fibroid(s) should be assessed by ultrasound. If further information about fibroid position, size, number and vascularity is needed, MRI should be considered. [2007]

1.5.14 Consider second-generation endometrial ablation as a treatment option for women with HMB and fibroids of 3 cm or more in diameter who meet the criteria specified in the manufacturers' instructions.

1.5.15 If treatment is unsuccessful: consider further investigations to reassess the cause of HMB, taking into account the results of previous investigations and offer alternative treatment with a choice of the options described in recommendation 1.5.10.

1.5.16 Pretreatment with a gonadotrophin-releasing hormone analogue before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus.

For further information, please see:

https://www.nice.org.uk/guidance/ng88.

https://www.nhs.uk/conditions/heavy-periods/#Causes

Rationale for recommendation

NICE’s Guideline Development Group considered the evidence (including 2 reviews, four randomised control trials and one cohort study comparing hysterectomy with other treatments) as well as the views of patients and the public and concluded that hysterectomy should not routinely be offered as first line

treatment for heavy menstrual bleeding. The Group placed a high value on the need for education and information provision for women with heavy menstrual bleeding.

Complications following hysterectomy are usually rare but infection occurs commonly. Less common complications include: intra-operative haemorrhage; damage to other abdominal organs, such as the urinary tract or bowel; urinary dysfunction –frequent passing of urine and incontinence. Rare complications include thrombosis (DVT and clot on the lung) and very rare complications include death. Complications are more likely when hysterectomy is performed in the presence of fibroids (non-cancerous growths in the uterus). There is a risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy. If oophorectomy (removal of the ovaries) is performed at the time of hysterectomy, menopausal-like symptoms occur.


https://www.nhs.uk/conditions/heavy-periods/#Causes


Appendix 2 – Diagnostic and Procedure Codes Dilatation and curettage (D&C) and Hysterectomy for heavy menstrual bleeding

GM072


GM072 – Dilatation and curettage (D&C) and Hysterectomy for heavy menstrual bleeding

OPCS-4 Procedure Codes:

Other specified curettage of uterus Q108

Other specified diagnostic endoscopic examination of uterus Q188

Dilation of cervix uteri and curettage of uterus NEC Q103

Abdominal hysterocolpectomy and excision of periuterine tissue Q071

Abdominal hysterectomy and excision of periuterine tissue NEC Q072

Abdominal hysterocolpectomy NEC Q073

Total abdominal hysterectomy NEC Q074

Subtotal abdominal hysterectomy Q075

Excision of accessory uterus Q076

Other specified abdominal excision of uterus Q078

Unspecified abdominal excision of uterus Q079

Vaginal hysterocolpectomy and excision of periuterine tissue Q081

Vaginal hysterectomy and excision of periuterine tissue NEC Q082

Vaginal hysterocolpectomy NEC Q083

Other specified vaginal excision of uterus Q088

Unspecified vaginal excision of uterus Q089

OPCS-4 Procedure Codes (that might be used)

Diagnostic endoscopic examination of uterus and biopsy of lesion of uterus Q181

Unspecified diagnostic endoscopic examination of uterus Q189

Transvaginal ultrasound examination of female genital tract Q555

Ultrasound of pelvis U092

Introduction of intrauterine contraceptive device Q121

Replacement of intrauterine contraceptive device Q122

Removal of displaced intrauterine contraceptive device NEC Q123

Removal of intrauterine contraceptive device NEC Q124


Other specified intrauterine contraceptive device Q128

Unspecified intrauterine contraceptive device Q129

Balloon ablation of endometrium Q162

Microwave ablation of endometrium NEC Q163

Free circulating saline ablation of endometrium Q164

Radiofrequency ablation of endometrium Q165

Photodynamic ablation of endometrium Q166

Endoscopic microwave ablation of endometrium Q176

Endoscopic balloon ablation of endometrium Q177

Open myomectomy Q092

Dilation of cervix uteri and curettage of products of conception from uterus Q101

Percutaneous transluminal embolisation of artery L713

Approach to organ under radiological control Y531

Approach to organ under ultrasonic control Y532

Approach to organ under computed tomography scan control Y533

Approach to organ under fluoroscopic control Y534

Approach to organ under image intensifier Y535

Approach to organ under video control Y536

Approach to organ under magnetic resonance imaging control Y537

Other specified approach to organ under image control Y538

Unspecified approach to organ under image control Y539

Uterine artery Z966

With the following ICD-10 diagnosis code(s):

Excessive and frequent menstruation with regular cycle N920

Excessive and frequent menstruation with irregular cycle N921

Excessive menstruation at puberty N922

Excessive bleeding in the premenopausal period N924

Postmenopausal bleeding N950

ICD-10 (Exceptions)

Submucous leiomyoma of uterus D250

Intramural leiomyoma of uterus D251


Subserosal leiomyoma of uterus D252

Leiomyoma of uterus, unspecified D259


Appendix 3 – Version History

Dilatation and curettage (D&C) and Hysterectomy for heavy menstrual bleeding GM072

The latest version of this policy can be found here [To add link when final policy approved]



0.2 16/01/2019 Policy approved at GM EUR Steering Group to progress to Clinical Engagement once the following amendments have been made: Commissioning Statement:

Policy Inclusion Criteria: o ‘Diagnostic’ added to the first title. o The word ‘solely’ added to the first sentence between the words ‘used’

and ‘to treat’. o The words ‘These procedures are’ added before the words ‘not

commissioned’. o Funding mechanism reworded for clarity.

‘Fitness for Surgery’ section added.

‘Best Practice Guideline’ section added.

‘Smoking and weight management’ section added. Rationale behind the policy statement:

Under ‘D&C’ the first paragraph reworded for clarity.

Under ‘Hysterectomy’: o ‘ALL of the following are met’ before the bullet points in the first

paragraph. o The first two bullet points merged

Epidemiology and Need: The following sentence added to the end of the second paragraph ‘Women with HMB symptoms that interfere with daily life are more likely to consult with a doctor for HMB6’. Glossary: Under Menorrhagia, the words ‘(heavy periods)’ added after ‘Heavy menstrual bleeding’. Appendix 1 – Evidence Review:

Search Strategy table amended to state what wasn’t cited in ‘The evidence’ and ‘NHS England Evidence Based Interventions evidence’ added.

‘Summary of the evidence’ o First paragraph reworded for clarity o ‘ALL of the following are met’ before the bullet points in the second

paragraph. o The first two bullet points merged

0.3 15/05/2019 The GM EUR Steering Group reviewed the feedback received during the period of clinical engagement and agreed the following changes to the policy:- Hysterectomy for heavy menstrual bleeding (HMB)

The sentence below has been removed on ‘It is important that healthcare professionals understand what matters most to each woman and support her personal priorities and choices.’ Typo on page 3 corrected ‘oblation’ now reads ‘ablation’. Following the above 2 amendments the GM EUR Steering Group approved the policy to progress through the governance process.




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