Food and alcohol disturbance among people who have undergone bariatric surgery.

There have been numerous investigations of aberrant eating and substance abuse among patients who have undergone bariatric surgery, which affects the metabolism and the pharmacokinetics of alcohol. However, there is a dearth of literature considering the complex interplay between changes in post-surgery food and alcohol consumption. Furthermore, despite the increasing recognition of issues surrounding replacing food consumption with alcohol consumption (Food and Alcohol Disturbance [FAD]), most emerging research has focused on young adult populations. This perspective reviews and synthesizes the small but growing body of research on the interplay between food and alcohol consumption, particularly FAD, and considers its application to bariatric surgery in general. There are unique considerations for patients who have undergone bariatric surgery. Patients experience altered gastric anatomy, which affects food and alcohol metabolism, and are advised to abstain from drinking alcohol after surgery. After reviewing the available literature, this perspective highlights future directions for research and practice in bariatric surgery.

Barriers to Bariatric Surgery: a Mixed Methods Study Investigating Obstacles Between Clinic Contact and Surgery.

PURPOSE: Populations most affected by obesity are not reflected in the patients who undergo bariatric surgery. Gaps in the referral system have been studied, but there is a lack of literature investigating obstacles patients encounter after first contact with bariatric surgery clinics. We aim to identify patient populations at risk for attrition during bariatric surgery evaluation and determine patient reported barriers to bariatric surgical care. MATERIALS AND METHODS: This study was a single institution, retrospective, mixed methods study from 2012 to 2021 comparing patients who underwent bariatric surgery to those that withdrew. Surveys were performed of patients who withdrew, collecting information on patient knowledge, expectations, and barriers. RESULTS: This study included 5982 patients evaluated in bariatric surgery clinic. Those who attained bariatric surgery (38.8%) were more likely to be White (81.2 vs. 75.6%, p<0.001), married (48.5 vs. 44.1%, p=0.004), and employed full time (48.2 vs. 43.8%, p=0.01). They were less likely to live in an area with low income (37.1 vs. 40.7%, p=0.01) or poverty (poverty rate 15.8 vs. 17.4, p<0.001). Of the 280 survey respondents, fear of complications, length of insurance approval process, and wait time between evaluation and surgery were the most reported barriers. CONCLUSION: Patients who undergo bariatric surgery were more likely to be White, married, employed full time, and reside in more resourced environments which is not reflective of communities most affected by obesity. The complexity of insurance coverage requirements was a major barrier to bariatric surgery and should be a focus of future healthcare reform.

Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 × 2 Factorial Randomized Controlled Trial.

BACKGROUND: Ventral incisional hernias are the most common complication after abdominal operation. Randomized trials have shown efficacy of prophylactic synthetic mesh and small bites. Adoption of these practices has been limited due to concerns with placement of synthetic mesh in contaminated cases and small bites in an overweight population. We sought to assess the efficacy of prophylactic biologic mesh and small bites to prevent postoperative major complications: ventral incisional hernias, surgical site infection, reoperation, and death. STUDY DESIGN: High-risk patients (overweight/obese, current smoker) undergoing abdominal operation with a midline incision (5 cm or greater) were randomized (2 × 2 factorial trial) to receive either sublay biologic mesh or no mesh and either small bites (0.5 × 0. 5cm) or large bites (1 × 1 cm) fascial closure. The primary outcome measure was major complications at 1 year postoperative. CONSORT guidelines were followed, and this study was registered on clinicaltrials.gov (NCT03148496). Assuming α = 0.05, ß = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher's exact test. RESULTS: A total of 107 patients were randomized: 52 (49%) to mesh, 55 (51%) to no mesh, 55 (51%) to small bites, and 52 (49%) to large bites. Of the patients, 16% were smokers, 31% were overweight, and 55% were obese. At 1 year postoperative, there were no differences in major complications between groups (mesh vs no mesh 21% vs 16%, p = 0.62; small vs large bites 18% vs 19%, p = 1.00). CONCLUSIONS: In this trial, biologic mesh and small bites appear to have no benefit. Further randomized trials are needed among high-risk patients before widespread adoption of prophylactic biologic mesh or small bites.

Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics: A Secondary Analysis of the CODA Randomized Clinical Trial.

Importance: Spanish-speaking participants are underrepresented in clinical trials, limiting study generalizability and contributing to ongoing health inequity. The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial intentionally included Spanish-speaking participants. Objective: To describe trial participation and compare clinical and patient-reported outcomes among Spanish-speaking and English-speaking participants with acute appendicitis randomized to antibiotics. Design, Setting, and Participants: This study is a secondary analysis of the CODA trial, a pragmatic randomized trial comparing antibiotic therapy with appendectomy in adult patients with imaging-confirmed appendicitis enrolled at 25 centers across the US from May 1, 2016, to February 28, 2020. The trial was conducted in English and Spanish. All 776 participants randomized to antibiotics are included in this analysis. The data were analyzed from November 15, 2021, through August 24, 2022. Intervention: Randomization to a 10-day course of antibiotics or appendectomy. Main Outcomes and Measures: Trial participation, European Quality of Life-5 Dimensions (EQ-5D) questionnaire scores (higher scores indicating a better health status), rate of appendectomy, treatment satisfaction, decisional regret, and days of work missed. Outcomes are also reported for a subset of participants that were recruited from the 5 sites with a large proportion of Spanish-speaking participants. Results: Among eligible patients 476 of 1050 Spanish speakers (45%) and 1076 of 3982 of English speakers (27%) consented, comprising the 1552 participants who underwent 1:1 randomization (mean age, 38.0 years; 976 male [63%]). Of the 776 participants randomized to antibiotics, 238 were Spanish speaking (31%). Among Spanish speakers randomized to antibiotics, the rate of appendectomy was 22% (95% CI, 17%-28%) at 30 days and 45% (95% CI, 38%-52%) at 1 year, while in English speakers, these rates were 20% (95% CI, 16%-23%) at 30 days and 42% (95% CI 38%-47%) at 1 year. Mean EQ-5D scores were 0.93 (95% CI, 0.92-0.95) among Spanish speakers and 0.92 (95% CI, 0.91-0.93) among English speakers. Symptom resolution at 30 days was reported by 68% (95% CI, 61%-74%) of Spanish speakers and 69% (95% CI, 64%-73%) of English speakers. Spanish speakers missed 6.69 (95% CI, 5.51-7.87) days of work on average, while English speakers missed 3.76 (95% CI, 3.20-4.32) days. Presentation to the emergency department or urgent care, hospitalization, treatment dissatisfaction, and decisional regret were low for both groups. Conclusions and Relevance: A high proportion of Spanish speakers participated in the CODA trial. Clinical and most patient-reported outcomes were similar for English- and Spanish-speaking participants treated with antibiotics. Spanish speakers reported more days of missed work. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

OBJECTIVE: Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair. BACKGROUND: Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair. METHODS: The trial was registered at clinicaltrials.gov (NCT03490266). Clinical outcomes included surgical site infection, surgical site occurrence, hernia occurrence, readmission, reoperation, and mortality. RESULTS: A total of 175 consecutive patients were approached that were deemed eligible for elective minimally invasive ventral hernia repair. In all, 124 were randomized and 101 completed follow-up at 2 years. Two-year follow-up was completed in 54 patients (83%) in the robotic arm and 47 patients (80%) in the laparoscopic arm. No differences were seen in surgical site infection or surgical site occurrence. Hernia recurrence occurred in 2 patients (4%) receiving robotic repair versus in 6 patients (13%) receiving laparoscopic repair (relative risk: 0.3, 95% CI: 0.06-1.39; P =0.12). No patients (0%) required reoperation in the robotic arm whereas 5 patients (11%) underwent reoperation in the laparoscopic arm ( P =0.019, relative risk not calculatable due to null outcome). CONCLUSIONS: Robotic ventral hernia repair demonstrated at least similar if not improved outcomes at 2 years compared with laparoscopy. There is potential benefit with robotic repair; however, additional multi-center trials and longer follow-up are needed to validate the hypothesis-generating findings of this study.

Presence of refractory GERD-like symptoms following laparoscopic fundoplication is rarely indicative of true recurrent GERD.

BACKGROUND: Laparoscopic fundoplication (LF) is the gold standard for gastroesophageal reflux disease (GERD). Recurrent GERD is a known complication; however, the incidence of recurrent GERD-like symptoms and long-term fundoplication failure is rarely reported. Our objective was to identify the rate of recurrent pathologic GERD in patients with GERD-like symptoms following fundoplication. We hypothesized that patients with recurrent GERD-like symptoms refractory to medical management do not have evidence of fundoplication failure as indicated by a positive ambulatory pH study. METHODS: This is a retrospective cohort study of 353 consecutive patients undergoing LF for GERD between 2011 and 2017. Baseline demographics, objective testing, GERD-HRQL scores, and follow-up data were collected in a prospective database. Patients with return visits to clinic following routine post-operative visits were identified (n = 136, 38.5%), and those with a primary complaint of GERD-like symptoms (n = 56, 16%) were included. The primary outcome was the proportion of patients with a positive post-operative ambulatory pH study. Secondary outcomes included proportion of patients with symptoms managed with acid-reducing medications, time to return to clinic, and need for reoperation. P values < 0.05 were considered significant. RESULTS: Fifty-six (16%) patients returned during the study period for an evaluation of recurrent GERD-like symptoms with a median interval of 51.2 (26.2-74.7) months. Twenty-four patients (42.9%) were successfully managed expectantly or with acid-reducing medications. Thirty two (57.1%) presented with GERD-like symptoms and failure of management with medical acid suppression and underwent repeat ambulatory pH testing. Of these, only 5 (9%) were found to have a DeMeester score of > 14.7, and three (5%) underwent recurrent fundoplication. CONCLUSION: Following LF, the incidence of GERD-like symptoms refractory to PPI therapy is much higher than the incidence of recurrent pathologic acid reflux. Few patients with recurrent GI symptoms require surgical revision. Evaluation, including objective reflux testing, is critical to evaluating these symptoms.

Prophylactic Mesh Reinforcement for Prevention of Midline Incisional Hernias: A Publication Bias Adjusted Meta-analysis.

OBJECTIVE: To systematically review the published literature on the use of prophylactic mesh reinforcement of midline laparotomy closures for prevention of VIH. SUMMARY OF BACKGROUND DATA: VIH are common complications of abdominal surgery. Prophylactic mesh has been proposed as an adjunct to prevent their occurrence. METHODS: PubMed, Embase, Scopus, and Cochrane were reviewed for RCTs that compared prophylactic mesh reinforcement versus conventional suture closure of midline abdominal surgery. Primary outcome was the incidence of VIH at postoperative follow-up ≥24 months. Secondary outcomes included surgical site infection and surgical site occurrence (SSO). Pooled risk ratios were obtained through random effect meta-analyses and adjusted for publication bias. Network meta-analyses were performed to compare mesh types and locations. RESULTS: Of 1969 screened articles, 12 RCTs were included. On meta-analysis there was a lower incidence of VIH with prophylactic mesh [11.1% vs 21.3%, Relative risk (RR) = 0.32; 95% confidence interval (CI) = 0.19-0.55, P < 0.001), however, publication bias was highly likely. When adjusted for this bias, prophylactic mesh had a more conservative effect (RR = 0.52; 95% CI = 0.39-0.70). There was no difference in risk of surgical site infection (9.1% vs 8.9%, RR = 1.08, 95% CI = 0.82-1.43; P = 0.118), however, prophylactic mesh increased the risk of SSO (14.2% vs 8.9%, RR = 1.57, 95% CI = 1.19-2.05; P < 0.001). CONCLUSION: Current RCTs suggest that in mid-term follow-up prophylactic mesh prevents VIH with increased risk for SSO. There is limited long-term data and substantial publication bias.

The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.

BACKGROUND: The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices. METHODS: The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications about the devices. The primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices. RESULTS: A total of 6152 devices were cleared through the 510(k) process in 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%). CONCLUSION AND RELEVANCE: There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

Is expectant management warranted in patients with ventral hernias and co-morbidities? A prospective, 5 year follow-up, patient-centered study.

BACKGROUND: Our aim was to report the natural history of operative versus expectant management of patients with ventral hernias and co-morbidities at five years. METHODS: This was a prospective observational study. Patients were managed with elective repair or expectantly, based on co-morbidities and patient/surgeon choice. Primary outcome was functional status. Patients were matched using optimal matching. Outcomes were compared using multivariable regression. RESULTS: A total of 197 patients were included (78 operative, 119 expectant) with median follow-up of 5.1 (3.2-5.5) years. In the matched-cohort (n = 80), 58 vs 68% were obese, and 88% vs 95% had a major comorbidity. Both groups had similar baseline functional status (p = 0.788), but only those repaired initially had significantly improved scores at five years (p < 0.050). Half (20) of patients managed expectantly crossed over to repair, and 15% (3) were emergent/urgent. CONCLUSION: Initial repair improves long-term functional status significantly compared to expectant management. Repair by hernia experts should be considered for high-risk patients.

Validation of the minimal clinically important difference for modified activities assessment scale.

BACKGROUND: The minimal clinically important difference (MCID) is the smallest change in patient-derived scores that is clinically important. We sought to validate the MCID of the modified activities assessment scale (mAAS). METHODS: Patients were surveyed prior to undergoing abdomen/pelvis CT scans and resurveyed one year later. Before resurvey, patients were asked if they had no change, worsening, or improvement in AW-QOL. The anchor-based MCID was calculated by taking a weighted mean of the difference between control (no change) and study (worsening/improved) groups. Distribution-based approach was calculated by one-half of the standard deviation in the QOL change. RESULTS: 52.8% of 181 patients self-reported no change, 39.2% reported improvement, and 8.3% reported worsening AW-QOL. The anchor-based approach MCID was 4. The distribution-based MCID was 16. CONCLUSION: Our study results validate prior work demonstrating similar ranges of the mAAS MCID. We recommend adopting an MCID of 5 and 15 for AW-QOL with mAAS.

Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194).

OBJECTIVE: To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA: Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS: This is the 2-year follow-up of a blinded randomized controlled trial from 2015 to 2017 at a safety-net academic institution. Obese patients (BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2 years. Complications included recurrence, reoperation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS: Of the 118 randomized patients, 108 (91.5%) completed a median (range) follow-up of 27.3 (6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ±â€Š2.6 vs 37.0 ±â€Š2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, P = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, P = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% vs 66.1%, P = 0.424, 1.14, 0.88-1.47). CONCLUSION: There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR.Clinical Trial Registration: This trial was registered with clinicaltrials.gov (NCT02365194).

Impact of Early Cholecystectomy on the Cost of Treating Mild Gallstone Pancreatitis: Gallstone PANC Trial.

BACKGROUND: The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs. STUDY DESIGN: A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy. RESULTS: Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs. CONCLUSION: In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.

The Evidence Behind Robot-Assisted Abdominopelvic Surgery : A Systematic Review.

BACKGROUND: Use of robot-assisted surgery has increased dramatically since its advent in the 1980s, and nearly all surgical subspecialties have adopted it. However, whether it has advantages compared with laparoscopy or open surgery is unknown. PURPOSE: To assess the quality of evidence and outcomes of robot-assisted surgery compared with laparoscopy and open surgery in adults. DATA SOURCES: PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials were searched from inception to April 2021. STUDY SELECTION: Randomized controlled trials that compared robot-assisted abdominopelvic surgery with laparoscopy, open surgery, or both. DATA EXTRACTION: Two reviewers independently extracted study data and risk of bias. DATA SYNTHESIS: A total of 50 studies with 4898 patients were included. Of the 39 studies that reported incidence of Clavien-Dindo complications, 4 (10%) showed fewer complications with robot-assisted surgery. The majority of studies showed no difference in intraoperative complications, conversion rates, and long-term outcomes. Overall, robot-assisted surgery had longer operative duration than laparoscopy, but no obvious difference was seen versus open surgery. LIMITATIONS: Heterogeneity was present among and within the included surgical subspecialties, which precluded meta-analysis. Several trials may not have been powered to assess relevant differences in outcomes. CONCLUSION: There is currently no clear advantage with existing robotic platforms, which are costly and increase operative duration. With refinement, competition, and cost reduction, future versions have the potential to improve clinical outcomes without the existing disadvantages. PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42020182027).

Gender Disparity Among American Medicine and Surgery Physicians: A Systematic Review.

BACKGROUND: Disparity exists between men and women physicians. We aimed to examine changes in gender disparity in the medical profession over the last two decades. The study reviewed publications on gender differences and the measures which have been implemented or suggested to rectify these disparities. METHODS: Pubmed, Embase, Scopus, and The Cochrane Library were searched in December 2019 using ("gender disparity" OR "gender gap" OR "pay gap" OR "gender discrimination") from 1998-2019. The sources list of reviewed articles was also used to retrieve more relevant articles. Articles about physicians in the United States were included, and Critical Appraisal Skills Programme (CASP) was used to evaluate the quality of the articles. RESULTS: In this systematic review that includes 49 studies, there is still disparity and discrimination in research, leadership, and pay between male and female physicians. Women have less leadership roles and progress at a slower rate to associate and full professor. Women publish less articles and have a lower h-index than men. Men earn $20,000 more a year after salary adjustment. More women than men experience negative comments about their gender (36% vs 4%), experience gender discrimination (65% vs 10%) and sexual harassment (30% vs 6%). CONCLUSIONS: Although substantial research exists on this topic, there remains significant room for improvement to achieve gender equality. Institutions and individuals should implement interventions to rectify this disparity .

Synthetic versus Biologic Mesh for Complex Open Ventral Hernia Repair: A Pilot Randomized Controlled Trial.

Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.

Patient quality of life before and after ventral hernia repair.

BACKGROUND: Recurrence is often reported as the primary outcome among studies of patients with hernias; however, there is growing interest in patient quality of life. The relationship between quality of life and recurrence is poorly understood. This study evaluates this relationship. METHODS: A secondary analysis of 3 prospective clinical trials was performed. The modified Activities Assessment Scale, a validated, abdominal wall-specific quality of life tool was used (1 = poor quality of life and 100 = perfect quality of life). Patients with and without a hernia recurrence were compared. Baseline quality of life, follow-up quality of life, and change in quality of life were measured. The relationship between quality of life and clinical outcomes was examined. RESULTS: A total of 238 patients were followed for median (range) 30 (14-44) months, of whom 31 (13.0%) had a clinical recurrence, whereas 207 (87.0%) had no clinical recurrence. Patients with recurrence were more likely to have a lower mean baseline quality of life (14 vs 26; P = .035), follow-up quality of life (42 vs 82; P < .001), and change in quality of life (19 vs 33; P < .018). The majority of patients with or without recurrence still experienced an improvement in quality of life (68% vs 79%; P = .142). CONCLUSION: Patients with lower baseline quality of life are likely to experience a recurrence following repair; however, most still report substantial improvements in quality of life. Assessing follow-up quality of life without accounting for baseline quality of life is incomplete; follow-up quality of life should be assessed with appropriate adjustment for baseline quality of life.

Port Site Hernias Following Laparoscopic Ventral Hernia Repair.

BACKGROUND: Port site hernias (PSH) are underreported following laparoscopic ventral hernia repair (LVHR). Most occur at the site of laterally placed 10-12-mm ports used to introduce large pieces of mesh. One alternative is to place the large port through the ventral hernia defect; however, there is potential for increased risk of surgical site infection (SSI). This study evaluates the outcomes when introducing mesh through a 10-12-mm port placed through the hernia defect. METHODS: This was a retrospective case series of patients who underwent LVHR in three prospective trials from 2014-2017 at one institution. All patients had mesh introduced through a 10-12-mm port placed through the ventral hernia defect. The primary outcome was SSI. Secondary outcomes were hernia occurrences including recurrences and PSH. RESULTS: A total of 315 eligible patients underwent LVHR with a median (range) follow-up of 21 (11-41) months. Many patients were obese (66.9%), recently quit tobacco use (8.8%), or had diabetes (18.9%). Most patients had an incisional hernia (61.2%), and 19.2% were recurrent. Hernias were on average 4.8 ± 3.8 cm in width. Two patients (0.6%) had an SSI. Fourteen patients had a hernia occurrence-13 (4.4%) had a recurrent hernia, and one patient (0.3%) had a PSH. CONCLUSION: During LVHR, introduction of mesh through a 10-12-mm port placed through the hernia defect is associated with a low risk of SSI and low risk of hernia occurrence. While further studies are needed to confirm these results, mesh can be safely introduced through a port through the defect.

Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.

OBJECTIVE: To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN: Pragmatic, blinded randomized controlled trial. SETTING: Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS: 124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS: Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES: The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS: Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION: This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION: Clinicaltrials.gov NCT03490266.