Sunday June 3, 2007 Istanbul Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias...

Sunday June 3, 2007 Istanbul

Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired?

Management of the Asymptomatic Inguinal Hernia

Robert J. Fitzgibbons MD, FACS

Harry E. Stuckenhoff Professor of Surgery

Creighton University School of Medicine

Omaha, Nebraska USA

Turkish Chapter of the American College of Surgeons

In 2007Inguinal Hernia Repair:

Has a Low Recurrence Rate Is an Outpatient Procedure Can be Performed Under Local

Anesthesia Is Associated with an Uneventful

Recovery in Most

Most North American Surgeons

Have been Taught That

The Indication for Elective Inguinal Herniorrhaphy

The Presence of a Hernia!

Regardless of Symptoms

Annual Inguinal Herniorrhaphy Rate

US 2800 Per MillionUK 1000 Per Million

So the Arguments Go Like This:

Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High

The Mortality Rate Associated with a Hernia Accident is Unacceptable

Progression is Inevitable, Incarceration and or Strangulation is Likely

Operation Becomes More Difficult the Longer it is Delayed

Patient Scenario

65 Year Old Healthy Male With a Unilateral, Easily Reducible Inguinal Hernia

He has No Symptoms and Has Not Had to Alter His Lifestyle in Any Way But His Wife is Worried About His Visible Bulge

He is Retired but Physically Active

Surgical Counseling

The Dreaded Complication

A Hernia AccidentStrangulation Bowel Obstruction

Surgical Counseling

The Hernia will Inevitably ProgressThere Will be a Penalty to Pay in Terms

of Recurrence and Complications Because Hernias Become More Difficult to Repair the Longer They Remain Unrepaired

Don’t Wait Until Your Health Declines!

Chronic Groin Pain

Annals of Surgery 244(2), August 2006

Sweden

Fränneby and Others. Annals of Surgery 244(2), August 2006

Sweden

Swedish Hernia Register 3000 Patients with Primary Hernia Repair

in 2000 2456 Patients (86%) Returned a postal

questionnaire 758 Patients (31%), Some Pain 144 cases (6%), Interfered with Work or

Leisure Activities

So Just How Valid are These Arguments For Routine Inguinal

Herniorrhaphy?

The Mortality Rate Associated with a Hernia The Mortality Rate Associated with a Hernia Accident is UnacceptableAccident is Unacceptable

Progression is Inevitable,Progression is Inevitable, Incarceration and or Strangulation is LikelyIncarceration and or Strangulation is Likely

Operation Becomes More Difficult the Longer it Operation Becomes More Difficult the Longer it is Delayedis Delayed

Risk of a Hernia AccidentWhat is Known

Adults Short Duration Old Age Femoral Hernia Coexisting Medical

Disease

Children Young Age Male Right Sided Hernia

Rai S, Chandra SS, Smile SR.. A study of the risk of strangulation and obstruction in groin hernias. Aust N Z J Surg 1998 Sep;68(9):650-4.India, 1985-1995

Who is at Risk?

Risk of a Hernia AccidentWhat is Not Known

The INCIDENCE

Risk of a Hernia AccidentWhat is Not Known

What is the Problem? Surgeons are Taught That All Inguinal

Hernias Should be Repaired to Prevent Complications. Therefore No Whole Groups of Patients With Hernias Untreated Exist

Variability of Surgeon Practice Patterns Surgeon A vs. Surgeon B

Therefore Only Historical Data Available

2 Unique Data Bases

Paul Berger’s Truss Clinic Berger P: Résultats de ľExamen de Dix Mille

Observations de Hernies. Paris, Extrait du neuvième congres francais de chirurgie 1895,1896

Cali Colombia Neutra R, Velez A, Ferreda R, Galan R. Risk of

incarceration of inguinal hernia in Cali, Columbia. Chron Dis 1981;34:561-564.

Berger’s Truss Clinic

1880 - 1884 Elective Herniorrhaphy Shunned 8633 Patients 242 Hernia Accidents

= Probability of Hernia Accident Per Year Is 0.0037

Cali Colombia

One Year (1965 – 1966) Government Initiative To Aggressively Examine A Stratified Random Sample Of Its Civilian Population To Determine The Frequency Of Common Conditions Such As Inguinal Hernia

Hospital Records

= Probability Of Hernia Accident Per Year Is 0.0038

Cumulative Probability of an Accident

=1 – (1 – p)e

p = probability of an accident per hernia patient per year (0.00375)

e = life expectancy* *National Center for Health Statistics: Vital statistics of the United

States, 1980. Life tables, 2(6). DHHS Publ. No. (PHS) 84-1104, 1984.National Center for Health Statistics: Vital statistics of the United States,

2001. Life tables, 52(14), 2004.

The Lifetime Risk of a Hernia Accident

18 yr 1/5.49

72 yr 1/27.03

One Hernia Accident Within Two Year Follow-up 4 Months After Randomization (0.3%)

One Additional Hernia Accident at 4 Years

Overall Accident Rate 0.0018 Events/ Patient Year

Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA

2006;295:285-292

Herniorrhaphy?

Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too HighToo High

Operative Mortality for Patients with Obstructed Inguinal Hernias

Authors

Beller & Colp(1926)

Frankau(1931)

Guillen & Aldrete(1970)

Anderson & Ostberg(1972)

Mortality Rate

2006;295:285-292

No Herniorrhaphy Related Mortality

Herniorrhaphy?

Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too HighToo High

Cumulative Probability of an Inguinal Hernia Becoming Irreducible

Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.

30% by10 Years

N= 699

Incarceration ≠ Strangulation

Many Men with Chronically Incarcerated Inguinal Hernias are Minimally Symptomatic

Cumulative Probability of an Inguinal Hernia Becoming Irreducible

Vs. Emergency Surgery10 patients

1 with infarcted small bowel1 with infarcted omentum

No Deaths or Serious Complication

Cumulative Probability of Pain

90% with Pain by 10 Years

Cumulative Probability of Pain

Leisure Activities Affected in Only 29%

Only 13% of Employed Patients had to Take Time Off Work Because of Hernia-related Symptoms.

Two Year Primary Outcomes:No differences in Pain or Physical function

WW 5.1% TFR3.2% , Difference 2.86%;95% Confidence Interval, -0.04% -5.72%, P=.52

WW ↑ .29 Points TFR ↑ .13% , Difference .16;95% Confidence Interval, -1.2 – 1.5

2006;295:285-292

Likelihood of a Hernia Repair in WW

So Just How Valid are These Arguments For Routine

Inguinal Herniorrhaphy?

Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too High Too High

MONTHS BETWEEN RANDOMIZATION AND SURGERY

PTOTALN=3536

N=288>6

Intraoperative (%) 3(1.04) 0.00 1.00 3(.85)

Postoperative Hernia site infection Wound hematoma Scrotum hematoma Orchitis Seroma Groin neuralgia Leg neuralgia Urinary retention Urinary infection Other

5(1.74)15(5.21)11(3.82)5(1.74)2(0.69)2(0.69)1(0.35)7(2.43)0(0.00)

12(4.17)

1(1.54)6(9.23)3(4.62)0(0.00)1(1.54)0(0.00)0(0.00)0(0.00)1(1.54)2(3.08)

1.000.24310.72800.58900.4580 1.000.18410.35720.1841 1.00

6(1.70)21(5.95)14(3.97)5(1.42)3(0.85)2(0.57)1(0.28)7(1.98)1(0.28)

14(3.97)

Total 49(17.01) 14(21.54) 0.3754 63(17.85)

2006;295:285-292

PERIOPERATIVE COMPLICATIONS

No Difference In Recurrence Rate

No Difference in Satisfaction with Care (97%)

2006;295:285-292

No Longer a Valid Argument! Conventional Anterior, Non-prosthetic

Marcy Bassini Moloney Darn Shouldice McVay Cooper’s Ligament Repair Miscellaneous Repairs

Conventional Preperitoneal, Non Prosthetic

Historical Interest Bassini

Conventional Anterior, Prosthetic Lichtenstein Tension Free

Hernioplasty Mesh Plug And Patch

Conventional Preperitoneal, Prosthetic The Anterior Approach

Read-rives The Posterior Approach

Wantz /Stoppa/Rives (Giant Prosthetic Reinforcement Of The Visceral Sac)

Nyhus /Condon (iliopubic Tract Repair) Kugel/Ugahary

Combination Anterior and Preperitoneal, Prosthetic

The Bilayer Prosthetic Repair Laparoscopic Inguinal Herniorrhaphy

Transabdominal Preperitoneal (TAPP) Totally Extraperitoneal (TEP) Intraperitoneal Onlay Mesh Procedure

(IPOM)

In Summary

Mortality For Strangulation is Not as Great as Once Thought

Increasing Morbidity Under Observation is Not Inevitable

There Isn't a Significant Penalty for Waiting Watchful Waiting is an Acceptable

Alternative to Routine Operation for a Minimally Symptomatic Inguinal Hernia

Ann Surg 2006;244: 167–173

Problems with the O’Dwyer Study

Conclusions

Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term

Chronic Pain May Be Beneficial to Patients in Improving

Overall Health May Reduce Potentially Serious Morbidity

Recruitment Problems160 Patients (Original Design = 250)

Older Age Group55 Years or Older

More Advanced HerniaVisable bulge Required

Short Follow/up1 Year

Conclusions

Chronic Pain

Conclusions

Chronic Pain

(But the WW Group Did Not Have to Endure an Operation!!!)

Conclusions

Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term Does Not Affect the Rate of Long-term

Chronic PainChronic Pain May Be Beneficial to Patients in Improving

Overall Health May Reduce Potentially Serious MorbidityMay Reduce Potentially Serious Morbidity

On An Intention-to-treat Analysis, There Was a Consistent Trend to Improvement of

About 5 Points in All of the SF-36 Dimensions (Except Emotional Role) in the

Operation Group Compared With the Observation Group

Conclusions

Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term Does Not Affect the Rate of Long-term

Chronic PainChronic Pain May Be Beneficial to Patients in Improving May Be Beneficial to Patients in Improving

Overall Health Overall Health May Reduce Potentially Serious Morbidity

“There Were 3 Serious Adverse Events in the Observation Group : 1 Patient Had an

Acute Hernia, 1 Had a Postoperative Stroke, and 1 Had a Myocardial Infarction

and Died Postoperatively. The Patient With the Acute Hernia had It Reduced at Another

Hospital.”

This is a SICK Group of Patients 2 Of the Operation Patients Died Before they

could be Operated (1 of Cancer,1 Cardiac) 9 More have Already Died

The Mean Time for Operation in the “Immediate Operation Group” was 103 Days

Caveats

Be Careful With ExtrapolationModerately Symptomatic Male?? Do Not Extrapolate to Woman!!

Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired?

Management of the Asymptomatic Inguinal Hernia

Robert J. Fitzgibbons MD, FACS

Harry E. Stuckenhoff Professor of Surgery

Creighton University School of Medicine

Omaha, Nebraska USA

Turkish Chapter of the American College of Surgeons

Sunday June 3, 2007 Istanbul Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias...

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