Accepted Manuscript

Patient-Centered Outcomes Following Laparoscopic Ventral Hernia Repair: ASystematic Review of the Current Literature

Michael Sosin, MD Ketan M. Patel, MD Maurice Y. Nahabedian, MD Parag Bhanot,MD

PII: S0002-9610(14)00163-9

DOI: 10.1016/j.amjsurg.2014.01.011

Reference: AJS 11139

To appear in: The American Journal of Surgery

Received Date: 6 November 2013

Revised Date: 17 December 2013

Accepted Date: 5 January 2014

Please cite this article as: Sosin M, Patel KM, Nahabedian MY, Bhanot P, Patient-Centered OutcomesFollowing Laparoscopic Ventral Hernia Repair: A Systematic Review of the Current Literature, TheAmerican Journal of Surgery (2014), doi: 10.1016/j.amjsurg.2014.01.011.

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Patient-Centered Outcomes Following Laparoscopic Ventral Hernia Repair: A Systematic

Review of the Current Literature

Michael Sosin, MD1, Ketan M. Patel, MD2, Maurice Y. Nahabedian, MD2, Parag Bhanot, MD1 Corresponding Author: Michael Sosin, MD Department of Surgery 3800 Reservoir Road, NW Pasquerilla Healthcare Center (PHC), Fourth Floor Washington, DC 20007 sosinmi@gmail.com telephone: 202-444-0481 fax: 877-376-2418 *Please address reprint requests to the Michael Sosin. Institution from which the work originated:

Georgetown University Hospital Department of Surgery1

Department of Plastic Surgery2

Sources of financial support: none Disclosure: Dr. Nahabedian is a consultant for Lifecell Corp. (Branchburg, NJ) and Sientra Corp. (Santa Barbara, CA). Dr. Parag Bhanot is a member of the Speakers Bureau for Lifecell Corp. (Branchburg, NJ). The rest of the authors have no conflict of interest or financial disclosures. No financial support was provided for preparation of this manuscript. Running Head: Lap Ventral Hernia Repair QoL Review Key words: laparoscopic ventral hernia; quality of life; abdominal wall; ventral hernia repair; QoL; patient reported outcomes Summary for Table of Contents: Health related quality of life (HRQoL) measures are becoming increasingly important in defining successful outcomes in ventral hernia repair (VHR). It is unclear what the impact of laparoscopic VHR has on patient reported outcomes, namely: HRQoL, pain, physical function, and patient satisfaction. Therefore, we conduct a systematic review of the current literature to integrate the available data on quality of life, pain assessment, functionality, and overall satisfaction following laparoscopic VHR.

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Abstract

Background

The purpose of this study was to systematically review patients that underwent laparoscopic

ventral hernia repair (LVHR) and assess QoL, pain, functionality, and patient satisfaction.

Data Sources

MEDLINE Pubmed and Cochrane database search identified 880 relevant articles. After limits

were applied, 14 articles were accepted for review. Analysis included HRQoL measures

including quality of life, pain, function, satisfaction, and mental and emotional well-being.

Conclusion

Fourteen studies were reviewed. Mean study size was 92.6 subjects (24-306), and mean defect

size was 71.7cm2. LVHR improved overall HRQoL in 6/8 studies. Thirteen studies assessing

pain demonstrating improved pain scores relative to preoperative levels and long term follow up.

LVHR was not associated with long term pain. Functionality improved in 12 studies. Return to

work ranged from 6-18 days postoperatively in 50% of studies, and physical function scores

improved in the remaining 50% of the studies. Patient satisfaction improved after LVHR in all

studies assessing patient satisfaction. Fixation methods did not influence HRQoL.

Laparoscopic repair was associated with improving mental and emotional well-being in 6/7

studies.

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Introduction

Ventral hernia repair (VHR) continues to be a prevalent procedure following laparotomy,

with an incidence of ventral hernia reported to be as high as 11%.1, 2 Over the last twenty years

there have been a number of advances, both in technique and mesh that have revolutionized

treatment.3, 4 Laparoscopic VHR (LVHR) has gained popularity with the additional benefit of

minimizing incisions and restoring continuity of the abdominal wall. The importance of patient-

centered outcomes including quality of life (QoL) measures, functional outcomes, pain

assessment, and overall satisfaction scores have become important variables to consider

following LVHR.

Studies reporting lower recurrence rates, fewer complications, and shorter hospital stays

have led to an increase in LVHRs.5-12 Avoiding dissection of previously scarred soft tissue and

disrupting previously placed meshes supports the rationale for laparoscopy.13 Despite the variety

of mesh fixation techniques and mesh type, a superior method of LVHR remains indeterminate.

Immediate and delayed postoperative complications such as seroma formation, infection,

fistula formation, small bowel obstruction, and pain remain the focus of surgical outcomes

following hernia repair.2, 14 While these factors are important in defining successful outcomes in

VHR, patient-reported outcomes are becoming equally important parameters.15 Consequently,

patient interpretation of improved health related quality of life (HRQoL) measures are becoming

increasingly important in defining successful outcomes. Increasing emphasis is being placed on

patient-reported HRQoL outcomes in decision making, clinical research, clinical practice, and

policy. A shift toward HRQoL measures in calculating cost-utility analysis and healthcare

reimbursements has brought these measures to the forefront of medicine.

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Currently a lack of consensus exists as to which HRQoL assessment tool is optimal in

measuring patient-reported outcomes after VHR. Although other disease processes have disease

specific HRQoL assessment tools, it is inherently challenging to implement them in VHR.16, 17

Ventral hernia remains a varying surgical problem from the defect severity and size, hernia type

(primary vs. secondary), operative technical options (laparoscopy, open, reconstructive), mesh

fixation methods (tacker, absorbable suture, fibrin sealant), mesh location (preperitoneal,

interposition, onlay), and mesh type (lightweight vs. medium or heavy, biologic vs. synthetic)

make investigations of general HRQoL measures difficult to assess and interpret across studies.

Published assessment tools (Table 1) have attempted to investigate such outcome measures;

however complicating matters further, quality of life (QoL) following VHR remains unclear.

Quality of life scores have been shown to be worse in the presence of a ventral hernia than that

of the general population.18 However, our goal was to determine whether LVHR ameliorates

those deleterious effects. To this end, we conducted a systematic review of the current literature

to integrate the available data on quality of life, pain assessment, functionality, and overall

satisfaction following laparoscopic ventral hernia repair.

Materials and Methods

The study design included a review of the MEDLINE Pubmed database and Cochrane

database using the search terms ‘hernia quality of life’, ‘ventral hernia quality of life’, and

‘abdominal wall quality of life’ for prospective and retrospective human studies in the English

language. Inclusion and exclusion criteria were developed and tailored to the MOOSE criteria.19

Inclusion criteria included studies that quality of life, functionality, and/or overall satisfaction for

patients with incisional or ventral hernia and for patients that had undergone LVHR. Exclusion

criteria included articles examining congenital abdominal wall defects (CAWD), inguinal, hiatal,

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or parastomal hernias, animal studies, case reports, or reviews. Articles that only reported

outcomes related to complications and/or recurrences without QoL, functionality, or overall

satisfaction were excluded from analysis. Studies that included only open ventral hernia repair

(OVHR) were excluded. Studies that included LVHR and OVHR underwent specific data

extraction to only incorporate data regarding LVHRs for analysis. Hernia size was not used as a

limit for exclusion criteria. The references of each study included in the review were screened to

identify potential citations not captured by the aforementioned search. Duplicate articles were

excluded to avoid redundancy. The search protocol and article selection (Figure 1) were

completed by one reviewer (M.S.).

Secondary outcomes were defined as: mental and emotional well-being, and the impact

of mesh fixation in HRQoL. Data analysis was completed using simple means allocating equal

weight to each study. Statistical significance was defined as p<0.05.

Results

Results from the initial search identified 880 potentially relevant articles. Of these

articles, 58 abstracts were reviewed, 35 were selected for full text article review, and 14 met

inclusion criteria and were ultimately included in this review (Table 2).

Included Study Characteristics

Primary outcomes of this systematic review include: general HRQoL, pain, functionality,

and overall satisfaction (Figure 2). Of the 14 included studies, 50% (7/14) were randomized

prospective trials, 42.9% (6/14) were nonrandomized prospective cohort studies, and 7.1% (1/14)

were nonrandomized retrospective cohort studies (Table 2). Mean study size was 92.6 subjects

with a range of 24-308 subjects. The majority of studies, 78.6% (11/14) completed patient

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accrual within the last 13 years (range 2001-2011). Accrual dates were not described in three

studies. Studies were not excluded if their (QoL) outcomes measures were secondary.

Overall HRQoL was assessed in 8 studies, pain was formally assessed in 13 studies, 12

studies assessed functionality, and 5 studies surveyed overall satisfaction after ventral hernia

repair. Several different assessment tools were utilized to assess HRQoL, pain, functionality,

and overall satisfaction. Of the 14 included studies 92.8% (13/14) utilized a validated

assessment tool, 42.8% (6/14) incorporated a non-validated assessment tool, and 7.1% (1/14)

only utilized a non-validated assessment tool. As shown in Figure 2, the SF-36, VAS, and a

subjective assessment termed ‘CSIQ’ (customized scale, survey, or questionnaire) were most

often used in the assessment of HRQoL, pain, functionality, and overall satisfaction.

The hernia defect size was not uniformly measured amongst the studies. However,

71.4% (10/14) of studies reported defect size calculated as area (cm2). Hernia defect was

described using diameter measurement (cm) in 21.4% (3/14) of studies. One study did not report

defect size. By extrapolating diameter in the 3 aforementioned studies, mean and median defect

size for the 13 studies was 71.7cm2 and 42.9cm2, respectively.

Health Related Quality of Life (HRQoL)

Despite the heterogeneity in the studies, several themes were recognized amongst the 8

studies that reported validated HRQoL measures. The SF-36 and SF-36v2 were used in the

majority of the studies assessing HRQoL 75% (6/8). Other assessment tools implemented in the

included studies are described in Figure 2. Patients with a ventral hernia had poorer HRQoL

scores versus the general population.20, 21 All but two articles demonstrated that LVHR

improved patients overall QoL.13, 20-25 Hope et al. and Colavita et al. did not demonstrate

improved QoL after LVHR because preoperative scores were not recorded. Rather they reported

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head to head comparisons of LVHR vs. OVHR.26, 27 Timing of postoperative evaluation varied

among studies. Improvement in HRQoL reached significance at 1 month21, 2 months24, 3

months23, 6 months21, and 2 years13. Ascencio et al. demonstrated that QoL improved at 1

month, 3 months, and 1 year with near significance.22 Improved HRQoL was also shown to be

significant in LVHR of recurrent hernias.13 Global improvement in HRQoL after LVHR was

confirmed by multiple studies.

Pain

The impact of pain on QoL is substantial and may have the most impact in the immediate

postoperative period. The VAS pain assessment tool was utilized in 61.5% (8/13) of the studies

evaluating pain. Other forms of pain assessment are described in Figure 2.

Pain scores were often measured preoperatively, immediately postoperatively, in the

subacute postoperative period, and during long term follow up (Figure 3). Seven articles

specifically studied only LVHR.13, 21, 23, 28-31 Pain scores were comparable or below preoperative

levels at 2 to 4 weeks and continued to improve long term.13, 21, 24, 25, 27, 30, 31 Number of tacks did

not correlate with pain.31 The incidence of chronic pain was 0% after LVHR.13, 21, 23, 24, 29, 30

All studies utilized a synthetic mesh, although brand of mesh and fixation methods varied

(Table 3). One study investigated differences between lightweight mesh and medium weight

mesh.29 No significant differences in pain were present at 1 week and 6 months, but duration of

analgesic consumption was longer in the medium weight mesh group (6.1 days vs. 1.6 days,

p<0.001).

Seven studies compared outcomes of laparoscopic versus open VHR with 6 studies

assessing pain. Each technique improved bodily pain scores and had similar long term

outcomes.20, 22, 24-26 Head to head comparison studies corroborated prior findings in LVHR-only

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studies in that a LVHR decreases pain scores compared to preoperative levels and pain scores

improve with time.

Measures of Physical Functionality

To assess abdominal wall function, 50% of studies (6/12) used the SF-36 or SF-36v2.

Other forms of functionality assessment are described in Figure 2. Time to return to work or

return to normal activity was included in functionality assessment. Patients after LVHR had

significantly higher scores on physical functioning, role physical, and physical component

summary (PCS) scores when compared to preoperative levels.20, 24, 26

Function and time to return to work varied among studies, as did mesh fixation

techniques. Time to return to work or normal activity ranged from 6 days to 18 days.21, 23, 24, 28-30

One study favored improved physical function with use of lightweight mesh versus medium

weight mesh29, one study found no difference in mesh fixation methods30, two studies reported

earlier return to work and better physical function scores with sutures versus tacks23, 31, two

studies found increased physical function scores with use of tacker fixation21, 23, and one study

found that use of fibrin sealant for fixation was associated with earlier return of normal activity.28

Role physical and physical function domains significantly improved at long term follow up after

LVHR regardless of fixation technique.13, 20, 21, 23, 24, 26-31

Patient Satisfaction

Overall patient satisfaction was assessed in 28.6% (4/14) of studies.21, 23, 25, 28 All studies

demonstrated the benefit of LVHR. Satisfaction progressively improved over time from

surgery.28 Eriksen et al. found that patient satisfaction averaged a score of 90 (on scale of 0-100)

on day 30 and 98 after 6 months.28 Correlation was found to be significant between pain and

patient satisfaction (p<0.001) and general well-being and patient satisfaction (p<0.001). Misra et

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al. demonstrated that satisfaction favored LVHR versus OVHR, but without reaching statistical

significance.25 Furthermore, no differences in patient satisfaction were observed in mesh

fixation techniques, specifically: sutures only, sutures and tacks, fibrin sealant, or tacks only.23, 28

All studies evaluating patient satisfaction after LVHR demonstrated favorable results with

respect to patient satisfaction.

Impact on Mental and Emotional Scores

Seven studies incorporated a form of assessing mental and emotional well-being. The

SF-36 comprised 85.7% (6/7) of the assessment tools used,20, 21, 23, 24, 26, 31 the other used the

GIQLI.13 Compared to preoperative scores, 6 studies found that role-emotional domain scores

and mental component scores (MCS) improved after LVHR.13, 20, 21, 23, 24, 26 Two studies found a

difference in fixation methods and their effect on mental and emotional well-being scores.23, 31

Bansal et al. demonstrated that the use of sutures and tacks significantly improvement role-

emotional and mental health scores versus only the use of suture fixation.23 Wassenaar et al.

showed that no difference in emotional well-being was seen when comparing suture and tacks

versus the use of only non-absorbable sutures.31 Laparoscopic VHR was associated with

improving mental and emotional well-being.

Discussion

Important QoL measures vary among studies attempting to elucidate the impact of a

disease process or medical condition. Quality of life outcomes have become an essential

principal in determining evidence-based guidelines. New data in VHR is emerging in the current

literature related to surgical outcomes. Historically, studies evaluating patient-centered

outcomes were less commonly performed. In this systematic review, 85.7% of the studies were

published after January 1, 2008 (range 2002-2012). The importance of evaluating patient-

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centered outcomes is becoming clear as health care policies and reimbursement are increasingly

using these metrics to modify the patient care process.

Different assessment tools have been created in an attempt to objectively assess a

patient’s quality of life after VHR (Table 2). However, many studies have also used subjective

assessment tools, which was termed ‘CSIQ’ (customized scale, interview, or questionnaire) in

our review. Observer bias, lack of comparison to the general population, interpretation

ambiguity, and the preclusion of integrating other studies in one large data pool should deter

future studies in utilizing subjective assessment tools. The Short-Form surveys (SF-36, SF-12,

SF-8) are standardized and validated HRQoL measuring instruments. Its implementation in

many different medical conditions continues to add to its appeal. The survey is divided into 8

measured scales that assess vitality, physical functioning, bodily pain, general health perceptions,

physical role functioning, emotional role functioning, social role functioning, and mental health.

The Short Form surveys are criticized for their purpose of assessing QoL in patients with chronic

diseases rather than those afflicted with acute disease processes such as ailments requiring

surgical intervention. Particularly in ventral hernias criticism of the SF-36 has resulted in the

development of other QoL assessment tools tailored for abdominal pathology such as the

Gastrointestinal Quality of Life Index (GIQLI) and the Carolina Comfort Scale (CCS) for

patients with abdominal mesh. Although other QoL assessment tools assess pain, the VAS pain

scale was most often used to assess pain as it is the most commonly used measures of pain

intensity in clinical and research settings.32

The various assessment tools utilized in HRQoL proved ventral hernia to be a condition

that significantly deteriorates a patient’s QoL. Patients were found to score worse in subjective

and objective abdominal functional assessment, pain, and emotional and mental well-being.

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Patients that underwent LVHR had lower abdominal wall strength than the general population,

but surgery improved abdominal wall functionality compared to preoperative levels. The

concept of improved overall QoL after a LVHR was corroborated in physical function, long term

pain, patient satisfaction, and mental and emotional well-being scores.

Although laparoscopic surgery has been advocated to decrease hospital stay, decrease

postoperative pain, and reduce incision size; the gold standard for repairing a ventral hernia

remains controversial.33 Laparoscopic VHR was not found to have a superior impact on quality

of life versus open hernia repair in our review. The evidence was equivocal in favoring a

laparoscopic repair over an open hernia repair with respect to improving postoperative pain and

physical function. In fact, various studies suggested an increase in immediate postoperative pain

on day 0-2 after LVHR. However, pain scores for all types of repairs tended to be below

preoperative levels by one month, and long term pain was rare. Several studies assessed mesh

fixation methods, which demonstrated equivocal effect on HRQoL, physical function, and short

and long term pain. Regardless of the approach, the benefits of a LVHR were overwhelmingly

apparent in improving HRQoL. Overall patient satisfaction was very high among patients

undergoing LVHR.

This review has shown the negative impact of ventral hernia on QoL, but the degree and

severity of impaired HRQoL remains variable. In addition, this review captures the difficulty in

studying ventral hernia as a uniform disease process in that physical function scores varied

among studies. The diversity in severity and size of a ventral hernia likely explains such a wide

range of scores. Likening scores from other HRQoL studies underscores the importance of

viewing abdominal wall defects as a spectral disease and truly determining whether surgical

intervention will improve overall functioning.

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The pitfalls of this study include the variety of utilized assessment tools, the varying size

of hernia defect, the diverse surgical approaches, a lack of uniform pain regimens, and the

inherent inability to integrate patient QoL assessment scores from one study to another.

However, the value of this review underscores the importance of optimizing patient-centered

outcomes following VHR. Understanding the impact of hernia surgery on QoL metrics will

allow clinicians to determine the most effective treatment strategies.

To date, the SF-36 serves as a popular method in assessing QoL in VHR. A tailored

assessment tool is essential to accurately define HRQoL standards in VHR. Additionally, more

randomized prospective comparative studies are necessary in determining patient-centered

outcomes among the different surgical techniques and the use of laporoscopy, mesh, and mesh

fixation methods.

Conclusion

Patients with a ventral hernia are more likely to report a lower health related quality of

life than the general population. It is unclear which method of LVHR improves HRQoL.

Laparoscopic ventral hernia repair improves patient-centered outcomes measures including

overall HRQoL, physical function, decreased long term pain, overall patient-reported satisfaction

after surgery, and emotional and mental well-being.

Acknowledgments

None.

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Table 1. Assessment Tools Utilized

┼ Studies that incorporated an assessment tool using a non-validated scale, an interview or

questionnaire in an attempt to evaluate pain, quality of life, satisfaction, or functionality are

identified in this review as CSIQ.

Table 2. Studies included in the systematic review.

µ diameter measurement, α confidence interval.

Table 3. Studies utilizing a mesh.

a – polypropylene, b – ePTFE (expanded polytetrafluoroethylene) or DualMesh, or Composix, c

– TiMesh, d – Parietex, e – Proceed, f – Physiomesh, g – Dulex, ¥ – information not provided by

authors

*absorbable material, **included absorbable and non-absorbable tacks

Figure 1. Flowchart describing the study selection process. CAWD – congenital abdominal wall

defect

Figure 2. Assessment tools utilized in this systematic review.

This table quantifies the use of each assessment tool stratified by quality of life, pain,

functionality, and overall satisfaction.

Figure 3. Reported time points of QoL assessment.

Studies included in this review reported predetermined time points to administer QoL

assessments to patients. Two studies[20,32] reported mean postoperative follow-up time, which

are included in this data set.

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Abbreviations in the manuscript: VHR = Ventral hernia repair

LVHR = Laparoscopic ventral hernia repair

OVHR = Open ventral hernia repair

HRQoL = Healthcare Related Quality of Life

QoL= Quality of Life

RCT = Randomized control trial

CAWD = Congenital Abdominal Wall Defect

VAS = Visual Analog Scale for Pain

SF-36 = Short Form 36

SF-36v2 = Short Form 36 version 2

GIQLI = Gastrointestinal Quality of Life Index

EQ5D = EuroQol-5D

BS4 = Biodex System 4

CCS = Carolina Comfort Scale

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Table 1. Assessment Tools Utilized

Assessment Tool Abbreviation Validated Studies Short Form 36 or Short Form 36 version 2 SF-36 or SF-36v2 Yes 6 Visual Analog Scale for Pain VAS Yes 8 Customized Scale, Interview, or Questionnaire┼

CSIQ No 7

Carolina Comfort Scale CCS Yes 2 EuroQol-5D EQ5D Yes 1 Gastrointestinal Quality of Life Index GIQLI Yes 1 Biodex System 4 BS4 Yes 1 ┼ Studies that incorporated an assessment tool using a non-validated scale, an interview or questionnaire in an attempt to evaluate pain, quality of life, satisfaction, or functionality are identified in this review as CSIQ.

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Table 2. Studies included in the systematic review. Reference Level of

evidence Study design Number of patients

(period of inclusion) QoL assessment tool(s)

Follow up (months) Hernia defect size (cm2)

Bansal et al. 2012 I Randomized prospective trial

110 (May 2007-Dec 2011)

SF-36v2, VAS, CSIQ: overall satisfaction

hour 1, hour 2, hour 24, 1 week, 1m, 3m 6m, 12m

9.1

Colavita et al. 2012 II Nonrandomized prospective cohort

402 (Sept 2007-July 2011)

CCS 1m, 6m, 12m, 24m 81.5 ± 93.1

Moreno-Egea et al. 2012 I Randomized prospective trial

102 (Jan 2005-Dec 2008)

VAS, CSIQ: return to daily activities

1 week, 1m, 6m, 12m, and 24m

7.4µ

Eriksen et al. 2011 I Randomized prospective trial

38 (Aug 2009-Mar 2010)

VAS, CSIQ: fatigue, discomfort, general well-being, time to resumption of normal daily activities, satisfaction

preop, hour 20, day 0-10, 1m

2.75 (1.5-6)µ

den Hartog et al. 2010 II Nonrandomized prospective cohort comparative study

42 (no dates) BS4 69.6m ± 21.6m no data

Itani et al. 2010 I Randomized prospective trial

83 (Feb 2004-Jan 2007)

SF-36v2, VAS preop, 2 weeks, 2m, 12m 50.5

Wassenaar et al. 2010 I Randomized prospective trial

172 (Aug 2005-July 2008)

SF-36, VAS preop, day 0, 2 weeks, 1.5m, 3m

19.2 ± 51.2

Asencio et al. 2009 I Randomized prospective trial

35 (no dates) EuroQol-5D (VAS included)

day 1-3, day 15, 1m, 12m 9.51µ (8.45-10.56)α

Eriksen et al. 2009 II Nonrandomized prospective cohort

31 (Nov 2005-May 2006)

SF-36, VAS, CSIQ: fatigue and nausea, satisfaction

preop, day 0-7, 2 weeks, 1m, 6m

41 (4-300)

Hope et al. 2008 III Nonrandomized retrospective cohort

15 (no data) SF-36, CCS preop, 6m (no data) 145

Nguyen et al. 2008 II Nonrandomized prospective cohort

50 (2004-2005) CSIQ: pain, return to work

1 week, 1m, 2m 95.5

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Uranues et al. 2008 II Nonrandomized prospective cohort

85 (Nov 2001-Dec 2006)

GIQLI preop, 24m 255 (48-416)

Mussack et al. 2006 II Nonrandomized prospective cohort

24 (Dec 2002-Jan 2004)

SF-36 16m (12m-25m) 130 (60-500)

Misra et al. 2006 I Randomized prospective trial

33 (April 2003-April 2005)

VAS, CSIQ: overall satisfaction

day 0, 1 week, 1m, 3m, 6m 42.12 (1-670)

µ diameter measurement, α confidence interval.

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Table 3. Studies utilizing a mesh.

Author Mesh Type Fixation Methods Colavita et al. 2012 Synthetica,b N/A den Hartog et al. 2010 Synthetic¥ N/A Itani et al. 2010 Syntheticb Sutures and Tacks Asencio et al. 2009 Syntheticb Sutures and Double Crown Tacks Hope et al. 2008 Syntheticb Sutures and Tacks Misra et al. 2006 Synthetica Suture* and/or Double Crown Tacks Mussack et al. 2006 Syntheticb Tacks Moreno-Egea et al. 2012 Syntheticc,d Sutures and Tacks* Bansal et al. 2012 Synthetice,f Sutures and Double Crown Tacks vs.

Sutures (only) Eriksen et al. 2011 Syntheticd Fibrin sealant vs. Tacks Wassenaar et al. 2010 Syntheticb Sutures* and Tacks vs. Double Crown

Tacks vs. Sutures (only)

Eriksen et al. 2009 Synthetice Double Crown Tacks Uranues et al. 2008 Syntheticb Sutures and Tacks Nguyen et al. 2008 Syntheticb,d,g Sutures vs. Tacks**

a – polypropylene, b – ePTFE (expanded polytetrafluoroethylene) or DualMesh, or Composix, c

– TiMesh, d – Parietex, e – Proceed, f – Physiomesh, g – Dulex, ¥ – information not provided by

authors

*absorbable material, **included absorbable and non-absorbable tacks

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Excluded

1 Article

Excluded

3 Articles reviewed 6 Articles 1

2 Articles included

7 Laparoscopic vs. Open studies 7 Laparoscopic studies

14 Studies included

6 Nonrandomized Prospective Cohort

14 Open hernia repairs 1 Collecting database proposal 2 Reviews 2 Article with data not reported 3 CAWD studies

22 Articles excluded

7 Nonrandomized Prospective Cohort

Excluded 1 Article excluded due to missing statistical data.

1 Nonrandomized Retrospective Cohort

Excluded

40 Citations identified as potentially applicable to review

Excluded

880 Titles identified

58 Abstracts reviewed

822 Articles

35 Articles reviewed

Excluded

24 Articles

13 Articles included

9 Abstracts reviewed

31 Redundant articles Excluded

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Figure 2. Assessment tools utilized in this systematic review.

0

1

2

3

4

5

6

7

8

9

Quality of Life Pain Functionality Overall Satisfaction

Num

ber o

f Stu

dies

SF36

VAS

CSQI

CCS

EQ50

GIQLI

BS4

This table quantifies the use of each assessment tool stratified by quality of life, pain, functionality, and overall satisfaction.

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Figure 3. Reported time points of QoL assessment.

Studies included in this review reported predetermined time points to administer QoL assessments to patients. Two studies[20,32] reported mean postoperative follow-up time, which are included in this data set.