ORIGINAL ARTICLES FROM THE ESA PROCEEDINGS

Prospective, Long-Term Comparison of Quality of Life in Laparoscopic Versus Open Ventral Hernia Repair Paul D. Colavita, MD, Victor B. Tsirline, MD, Igor Belyansky, MD, Amanda L. Walters, MS, Amy E. Lincourt, PhD, Ronald F. Sing, DO, and B. Todd Heniford, MD

Objectives: To compare laparoscopic ventral hernia repair (LVHR) versus open ventral hernia repair (OVHR) for quality of life (QOL), complications, and recurrence in a large, prospective, multinational study. Introduction: As recurrence rates have decreased for LVHR and OVHR, QOL has become an extremely important differentiating outcomes measure. Methods: A prospective, international database was queried from September 2007 to July 2011 for LVHR and OVHR. Carolinas Comfort Scale (CCS) was utilized to quantify QOL (pain, movement limitation, and mesh sensation) preoperatively and at 1, 6, and 12 months postoperatively. Results: A total of 710 repairs included 402 OVHR and 308 LVHR. Demographics were mean age 57.1 ± 13.3 years, 49.6% male, 21.7% recurrent hernias, mean body mass index of 30.3 ± 6.6, and mean defect size of 89.4 ± 130.8. Preoperatively, 56.9% had pain, and 53.2% experienced movement limitation. At 1-month follow-up, 587 (82.7%) patients were provided CCS scores; more LVHR patients experienced pain (P < 0.001) and movement limitations (P < 0.001). At 6 and 12 months, there were no differences in QOL with 466 (65.6%) and 478 (67.3%) patients responding, respectively. After controlling for confounding variables, LVHR was independently associated with more frequent discomfort [odds ratio (OR) = 1.9, confidence interval (CI): 1.2–3.1], movement limitation (OR = 1.6, CI: 1.0–2.7), and overall symptoms (OR = 1.6, CI: 1.0–2.6) at 1 month. LVHR resulted in a shorter length of stay (LOS) (P < 0.001) and fewer infections (P = 0.004), but overall complication rates were equal. Recurrence rates were also equal (P = 0.66). Conclusion: In the largest, prospective QOL study comparing LVHR and OVHR, LVHR is associated with a decrease in QOL in the short term. LOS and infection rates are decreased in LVHR, but overall complication and recurrence rates are equal. Keywords: Carolinas Comfort Score, complication, incisional hernia repair, laparoscopic ventral hernia repair, laparoscopic versus open, open ventral hernia repair, quality of life, ventral hernia (Ann Surg 2012;256: 714–723)

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n estimated 348,000 ventral hernia repairs (VHRs) were performed in 2006 in the United States,1 and it has been projected that 300,000 VHRs are performed annually in Europe.2 In 2009, 27.4% of VHRs with mesh were performed laparoscopically in the United States based on billing data from the Nationwide Inpatient Sample (unpublished). Since its first description in the early 1990s,3 laparoscopic ventral hernia repair (LVHR) has been shown to be both safe and effective.4,5 It has gained popularity with time and has From the Division of Gastrointestinal and Minimally Invasive Surgery, Carolinas Laparoscopic and Advanced Surgery Program, Carolinas Medical Center, Charlotte, NC. Disclosure: No funding was received for this work from any of the following organizations: National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), or others. The authors declare no conflicts of interest. Reprints: B. Todd Heniford, MD, 1025 Morehead Medical Drive, Suite 300, Charlotte, NC 28204. E-mail: [email protected]. C 2012 by Lippincott Williams & Wilkins Copyright  ISSN: 0003-4932/12/25605-0714 DOI: 10.1097/SLA.0b013e3182734130

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been extensively compared with open ventral hernia repair (OVHR). Initial comparisons examined complication and recurrence rates. A number of studies have shown LVHR to be associated with fewer recurrences,6–8 lower overall complications,6–9 shorter length of stay (LOS),6–8,10,11 and lower infection rates.8,11,12 Other studies describe no difference in recurrence, complications, or LOS.13 In contrast, one prospective randomized trial demonstrated increased complications in LVHR with no difference in LOS or recurrence compared with OVHR through 1-year follow-up.14 Another prospective trial showed no difference in recurrence rate with long-term follow-up.11 Although LVHR is often associated with an overall reduction in postoperative morbidity,10 some suggest that it may increase the frequency of severe complications, such as bowel injury.15,16 This notion has been strongly challenged, owing to the lack of previous open data and the inherent risk of the procedure. In the face of historically low recurrence rates after prosthetic reinforcement of hernia repairs and improvement and standardization of technique, quality of life (QOL) has become one of the leading outcome measures in hernia surgery.17,18 QOL comparisons between LVHR and OVHR have been performed in few studies with mixed results. It has been suggested that LVHR is associated with less pain than OVHR at 6 months postoperatively,19 as well as 1 year.15 Other studies have shown no difference in pain scores after 3 months11 and no difference in pain after postoperative day 3 through 1 year of follow-up.14 These studies report outcomes in a small number of patients, focused primarily on pain with visual analog scales (VAS) or utilized generic QOL instruments, geared neither toward surgery, in general, nor toward hernia repair, in particular. Specific analyses of factors affecting QOL after LVHR have also been performed. Long-term chronic pain after LVHR ranges from 3% to 4.5%.4,12,20 Both the use of tacks21 as well as transfascial sutures4,22 for mesh fixation have been linked to postoperative pain. Studies have found no difference between the 2 fixation methods at multiple follow-up time points,23,24 or have linked sutures to higher pain than tacks at 1 month postoperatively, with no difference longterm.25 We have previously studied the effects of fixation method and long-term QOL in LVHR26 and found that transfascial sutures result in more discomfort only during the first month after surgery. Conversely, there have been very few publications examining variables affecting QOL after OVHR. One study compared light- and heavy-weight mesh and concluded that mesh weight had no effect on QOL after OVHR.27 The purpose of this study is to compare QOL outcomes after OVHR and LVHR in short- and long-term follow-up, as well as the associated LOS and complication and recurrence rates. The study utilized a prospective, international hernia registry comprising a diverse population of surgeons and providers and a proven QOL measurement tool specific for hernia outcomes study.

METHODS International Hernia Mesh Registry Analysis was performed of the International Hernia Mesh Registry (IHMR), a multinational, prospective database. More than 30 centers in the United States, Canada, Europe, and Australia Annals of Surgery r Volume 256, Number 5, November 2012

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Annals of Surgery r Volume 256, Number 5, November 2012

contribute to the registry. Inclusion and exclusion criteria for the registry have been previously described28 and are contained in Table 1. The registry contains patient data regarding demographics, comorbidities, hernia characteristics (location, primary versus recurrent, number of recurrences, and defect size), operative details (laparoscopic versus open; type of mesh; mesh placement; fixation techniques—type and number of sutures, tacks, and/or glue; operative time), discharge data, and complications. In addition, the registry contains patient-reported QOL data at regular intervals. The QOL surveys are completed by patients at home or in the office in the absence of a physician or other office personnel with guaranteed anonymity, to minimize expectation bias.28,29 The IHMR was queried for VHRs from September 2007 to July 2011. Examined outcomes included: LOS, complications, recurrence, and QOL scores at 1, 6, and 12 months postoperatively.

Carolinas Comfort Scale and QOL Outcomes Carolinas Comfort Scale (CCS) is a hernia-specific QOL survey that evaluates the incidence and severity of pain, activity limitation, and mesh sensation (referred to herein as “domains”) in 7 different activities, as well as pain and mesh sensation at rest. The CCS is a validated assessment tool for early and long-term QOL symptoms after hernia repair and has been shown to be superior to the generic Short Form 36 (SF-36) questionnaire for patients who undergo hernia repair with mesh.18,30–32 At 1-, 6-, 12-, and 24-month follow-up, CCS scores were compared between patients undergoing LVHR and OVHR. CCS scores are reported on a 6-point Likert scale for each combination of activity with QOL domain, where zero corresponds to no symptoms and 5 corresponds to disabling symptoms. To compare each overall QOL domain, the maximum score from all activities corresponding to that domain was used for each patient. Maximum scores of 0 (none) or 1 (minimal and not bothersome) were classified as asymptomatic, whereas scores of 2 (minimal but bothersome) or higher were considered symptomatic. To examine the effect of complications on QOL, frequency of symptoms between all VHRs with and without complications were compared for each QOL domain at each follow-up period. Two outcomes were assessed for their effects on QOL: recurrence and abdominal wall complications, which were defined as the presence of hematoma, seroma, or infection.

LVHR versus OVHR: Long-Term QOL, Complications

Statistical Analysis The data were stored and analyzed using SAS Software version 9.2 (SAS Institute, Inc, Cary, NC). The Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were used to compare continuous and ordinal variables and Pearson χ 2 and Fisher exact tests were used to compare categorical variables. All group comparisons were unpaired. Temporal changes in quality of life were evaluated using paired comparisons via the Wilcoxon matched pairs test. Statistical significance was set at P < 0.05. Multivariate logistic regression was performed to calculate the adjusted odds ratios for the incidence of postoperative QOL symptoms for patients undergoing VHR. All variables entered as covariates [patient age, gender, country, body mass index (BMI), defect size, mesh weight, recurrence, incidence of skin complications, incidence of preoperative QOL symptoms] were selected a priori on the basis of established or potential clinical risk or were considered potential confounders for the effect of surgical technique on QOL. Potential clinical risk factors were identified on the basis of their prevalence in symptomatic or asymptomatic patients regardless of the LVHR/OVHR classification. The estimated odds of postoperative QOL symptoms were adjusted for all covariates. The statistical significance of the association between postoperative QOL symptoms and LVHR/OVHR classification, recurrence, or abdominal wall complications was assessed using the Wald χ 2 test. Although significantly different between LVHR and OVHR, fixation techniques were not included as covariates. The distribution of fixation technique is inherent to the laparoscopic or open approach; as detailed in the "Results" section, more than 94% of LVHR and less than 6% of OVHR employed tacks for fixation. Including the fixation methods in the regression models increases the likelihood of covariate interference with our variable of interest, laparoscopic versus open technique.

RESULTS A total of the 710 VHRs met inclusion criteria, including 402 OVHR and 308 LVHR. These patients supplied a preoperative CCS score and at least 1 follow-up CCS score. Demographic, hernia, and comorbid data are shown in Table 2. Operative characteristics are detailed in Table 3. LOS and complications are compared in Table 4. QOL results are depicted in Figures 1 and 2. At 1-, 6-, and 12-month

TABLE 1. Inclusion and Exclusion Criteria for International Mesh Hernia Registry Inclusion Criteria Patients who provide a written informed consent Male or female patients 18 years or older Patients who are literate and able to understand a language available in the registry patient questionnaires Patients scheduled to receive a surgically implanted mesh product for repair of a hernia defect Patients who agree to provide long-term, outcomes data Patients who agree to provide contact information

Exclusion Criteria Patients who are