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
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 firstname.lastname@example.org 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.
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.
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.
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
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
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.
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,
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
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
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.
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,
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
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...