Patient-centered outcomes following laparoscopic ventral hernia repair: a systematic review of the current literature

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  • 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.

    This is a PDF file of an unedited manuscript that has been accepted for publication. As a service toour customers we are providing this early version of the manuscript. The manuscript will undergocopyediting, typesetting, and review of the resulting proof before it is published in its final form. Pleasenote that during the production process errors may be discovered which could affect the content, and alllegal disclaimers that apply to the journal pertain.

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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

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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

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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 wa...

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