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.

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.

Safety and Feasibility of Performing Antireflux Procedures at a Safety Net Hospital.

INTRODUCTION: One-half of Americans have limited access to health care; these patients often receive care through safety net hospitals, which are associated with worse medical outcomes. This study aims to compare the outcomes of patients who received foregut surgery at a safety net hospital to those at a private or university hospital. We hypothesized that patients treated at the safety net hospital will have a greater rate of radiographic recurrence and reoperations. METHODS: A retrospective study was conducted on patients who underwent hiatal hernia repair or fundoplication for gastroesophageal reflux disease at an affiliated safety net, private, or university hospital from June 2015 to May 2020. The primary outcome was radiographic recurrence. The secondary outcomes included reoperation and symptom recurrence. Analysis was performed using analysis of variance, chi-square, and logistic regression. RESULTS: A total of 499 patients were identified: 157 at a safety net hospital, 233 at a private hospital, and 119 at a university hospital. The median (interquartile range) follow-up was 16 (13) mo. The safety net hospital treated more Hispanics, females, and patients with comorbidities. Large hiatal hernias were more common at the safety net and private hospitals. Robotic surgery was more frequently at the university hospital. There was no difference in radiographic recurrence (13.4% versus 19.7% versus 17.6%; P = 0.269), reoperation (3.8% versus 7.2% versus 6.7%; P = 0.389), or postoperative dysphagia (15.3% versus 12.6% versus 15.1%; P = 0.696). On logistic regression, there were no differences in outcomes among institutions. CONCLUSIONS: This study suggests that despite the challenges faced at safety net hospitals, it could be feasible to safely perform minimally invasive foregut surgery with similar outcomes to private and university hospitals.

The Role of Biologic Mesh and Fundoplication in the Surgical Management of Hiatal Hernias: A Multicenter Evaluation.

INTRODUCTION: Hiatal hernia repair is associated with substantial recurrence of both hiatal hernia and symptoms of gastroesophageal reflux (GER). While small randomized controlled trials demonstrate limited differences in outcomes with use of mesh or fundoplication type, uncertainty remains. METHODS: A multicenter, retrospective review of patients undergoing surgical treatment of hiatal hernias between 2015 and 2020 was performed. Patients with mesh and with suture-only repair were compared, and partial versus complete fundoplication was compared. Primary outcomes were hernia recurrence and occurrence of postoperative GER symptoms and dysphagia. Multivariable regression was performed to assess the effect of each intervention on clinical outcomes. RESULTS: A total of 453 patients from four sites were followed for a median (IQR) of 17 (13) months. On multivariate analysis, mesh had no impact on hernia recurrence (odds ratio 0.993, 95% CI: 0.53-1.87, p = 0.982), and fundoplication type did not impact recurrence of postoperative GER symptoms (complete: odds ratio 0.607, 95% CI: 0.33-1.12, p = 0.112) or dysphagia (complete: odds ratio 1.17, 95% CI: 0.56-2.43, p = 0.677). CONCLUSION: During hiatal hernia repair, mesh and fundoplication type do not appear to have substantial impact on GER symptoms, dysphagia, or hernia recurrence. This multicenter study provides real-world evidence to support the findings of small RCTs.

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).

Reproducing Statistics Performed in Published Randomized Controlled Trials.

INTRODUCTION: Randomized controlled trials (RCT) represent evidence at the lowest potential risk for bias. Clinicians in all specialties depend upon RCTs to guide patient care. Issues such as statistical discordance, or reporting statistical results that cannot be reproduced, should be uncommon. Our aim was to confirm the statistical reproducibility of published RCTs. METHODS: PubMed was searched using "randomized controlled trial." Studies were selected using a random number generator. Studies were included if the primary outcome could be reproduced using the data and statistical test reported in the manuscript. The reproduced p-value from our analysis and the published p-value were compared. Primary outcome was the number of studies that reported p-values that differed in statistical significance (crossed p-value=0.05) from the reproduction analysis. Assuming an alpha of 0.05, a beta of 0.80, an estimated rate of statistical discordance of 5% for RCTs, a total of at least 568 studies were required. RESULTS: Overall, 572 RCTs were selected involving six specialties. Of these, 45% were positive (p<0.05) studies. Eleven (2%) published results that differed from the reproduction analysis and crossed the p=0.05 threshold. All 11 studies were positive studies (while the reproduction analysis demonstrated p≥0.05). CONCLUSION: Less than 5% of published RCTs reported a discordant p-value that crossed the "p=0.05" threshold. Although the occurrence is uncommon, the existence of even one RCT publishing nonreproducible results is concerning. Future studies should seek to identify why some RCTs report discordant statistics and how to prevent this from occurring.

Review of SAGES GERD guidelines and recommendations.

BACKGROUND: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed evidence-based guidelines for the management of patients with gastroesophageal reflux disease (GERD). The aim of this study is to evaluate guidelines lacking agreement among experts (grades B-D) or lacking support from randomized controlled trials (levels II-III). METHODS: Six guidelines were chosen for evaluation. A retrospective review of a multicenter database of patients undergoing fundoplication surgery for treatment of GERD between 2015 and 2020 was performed. Patients that underwent a concurrent gastrectomy or were diagnosed with pre-operative achalasia were excluded. Demographics, pre-operative, intra-operative, and post-operative variables were collected. Post-operative outcomes were evaluated based on selected SAGES guidelines. Outcomes were assessed using multivariable regression or stratified analysis for each guideline. RESULTS: A total of 444 patients from four institutions underwent surgery for the management of GERD with a median (interquartile range) follow-up of 16 (13) months. Guidelines supported by our data were (1) robotic repair has similar short-term outcomes to laparoscopic repair, (2) outcomes in older patients are similar to outcomes of younger patients undergoing antireflux surgery, and (3) following laparoscopic antireflux surgery, dysphagia has been reported to significantly improve from pre-operative values. Guidelines that were not supported were (1) mesh reinforcement may be beneficial in decreasing the incidence of wrap herniation, (2) a bougie has been found to be effective, and (3) the long-term effectiveness of fundoplication in obese individuals (BMI > 30) has been questioned due to higher failure rates. CONCLUSION: Many SAGES GERD guidelines not receiving Grade A or Level I recommendation are supported by large, multicenter database findings. However, further studies at low risk for bias are needed to further refine these guidelines.

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).

Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcomes of robotic versus laparoscopic ventral hernia repair (LVHR) at 1-year postoperative. SUMMARY OF BACKGROUND DATA: Despite a relative lack of research at low risk for bias assessing robotic ventral hernia repair (RVHR), the growth of RVHR has been rapid. We previously reported short-term results of the first randomized control trial comparing RVHR versus LVHR; there was no clear difference in clinical outcomes but increased operative time and cost with robotic repair. METHODS: Patients from a multicenter, blinded randomized control trial comparing RVHR versus LVHR were followed at 1 year. Outcomes included wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis). RESULTS: A total of 124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed 1-year follow-up. Baseline demographics were similar in both groups. No differences were seen in wound complication (15% vs 15%; P = 0.899), hernia recurrence (7% vs 9%; P = 0.576), or readmission (2% vs 6%; P = 0.251). No patients underwent reoperation in the robotic arm, whereas 5 (9%) did in the laparoscopic arm (P = 0.020). No differences were seen in patient-reported outcomes. Both arms reported clinically significant improvements in functional status, low pain scores, and high satisfaction scores at 1-year post repair. CONCLUSION: This study confirms that robotic ventral hernia repair is safe when compared to laparoscopy. Further studies are needed to confirm these findings.

Is robotic surgery feasible at a safety net hospital?

BACKGROUND: Robotic surgery offers potential advantages of improved ability to complete procedures using a minimally invasive approach, recovery, and clinical outcomes. It has been previously established that safety net hospitals are outliers for surgical complications. As such, the adoption of new technology may not achieve the same outcomes as other institutions. We hypothesized that, compared to laparoscopic and open surgeries, robotic surgeries have fewer post-operative Clavien-Dindo complications at our safety net hospital. METHODS: All robotic surgeries performed from 2017 to 2019 at a single, safety net hospital were reviewed. Cases were matched 1:3 to laparoscopic controls. Surgeries commonly performed open were additionally matched 1:3 to open counterparts. The primary outcome was Clavien-Dindo complications at 90 days post-operatively. Secondary outcomes included inadvertent enterotomy, conversion to open, operative duration, wound class, surgical site infection (SSI), surgical site occurrence (SSO), length of stay (LOS), reoperation, readmission, and recurrence. RESULTS: A total of 160 robotic surgeries were included and matched to 480 laparoscopic surgeries and 108 open surgeries. Open surgeries were associated with greater risk of Clavien-Dindo complication (OR = 2.7, p = 0.040, 95% confidence interval 1.0-6.9) than either robotic or laparoscopic surgeries. Robotic cases had increased operative duration when compared to laparoscopic (p < 0.001) but not open cases (p = 0.093). No difference was seen in enterotomy, conversion to open, SSI, SSO, LOS, reoperation, readmission, or recurrence between robotic and laparoscopic, and robotic and open cases. CONCLUSION: Robotic surgery is safe and feasible at a safety net hospital. Robotic and laparoscopic surgeries were associated with fewer Clavien-Dindo complications than open surgery, but no differences were seen between robotic and laparoscopic cases. Robotic surgery, compared to both laparoscopic and open surgery, had longer operative durations. Further studies are needed to assess the value of robotic as opposed to laparoscopic surgery in a safety net setting.

Primary Fascial Closure During Laparoscopic Ventral Hernia Repair Improves Patient Quality of Life: A Multicenter, Blinded Randomized Controlled Trial.

BACKGROUND: Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR). OBJECTIVE: The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL). METHODS: In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square. RESULTS: A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ±â€Š28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups. CONCLUSIONS: Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02363790).

Prevalence and Impact on Quality of Life of Occult Hernias among Patients Undergoing Computed Tomography.

BACKGROUND: With the widespread use of advanced imaging there is a need to quantify the prevalence and impact of hernias. We aimed to determine the prevalence of abdominal wall hernias among patients undergoing computed tomography (CT) scans and their impact on abdominal wall quality of life (AW-QOL). METHODS: Patients undergoing elective CT abdomen/pelvis scans were enrolled. Standardized physical examinations were performed by surgeons blinded to the CT scan results. AW-QOL was measured through the modified Activities Assessment Scale. On this scale, 1 is poor AW-QOL, 100 is perfect, and a change of 7 is the minimum clinically important difference. Three surgeons reviewed the CT scans for the presence of ventral or groin hernias. The number of patients and the median AW-QOL scores were determined for three groups: no hernia, hernias only seen on imaging (occult hernias), and clinically apparent hernias. RESULTS: A total of 246 patients were enrolled. Physical examination detected 62 (25.2%) patients with a hernia while CT scan revealed 107 (43.5%) with occult hernias. The median (interquartile range) AW-QOL of patients per group was no hernia = 84 (46), occult hernia = 77 (57), and clinically apparent hernia = 62 (55). CONCLUSIONS: One-fourth of individuals undergoing CT abdomen/pelvis scans have a clinical hernia, whereas nearly half have an occult hernia. Compared with individuals with no hernias, patients with clinically apparent or occult hernias have a lower AW-QOL (by 22 and seven points, respectively). Further studies are needed to determine natural history of AW-QOL and best treatment strategies for patients with occult hernias.

Gender Disparity Among Surgical Peer-Reviewed Literature.

BACKGROUND: Women remain under-represented in academic surgery despite increasing percentages of female surgeons and surgery residents. Publications and leadership positions are used for hiring and promoting academic surgeons. We sought to determine the disparity of female authorship when compared with male authors in surgical peer-reviewed publications. METHODS: PubMed was searched for surgical publications from the United States. Obstetrics and gynecology was selected as a control specialty owing to its history of high female representation. Thirteen other surgical specialties were randomly selected from the Accreditation Council for Graduate Medical Education specialty list. Manuscripts from four time periods, 2000-2005, 2006-2010, 2011-2015, and 2016-2017, were randomly selected, and the gender of the first and last authors was determined. The Accreditation Council for Graduate Medical Education and Association of American Medical Colleges databases were used to determine women representation in surgery. Trends were assessed using the Cochran-Armitage test. RESULTS: In total, 560 manuscripts in 14 specialties were reviewed. In the control specialty, 51% of first authors were female compared with 18% of those in study specialties, and 39% of last authors were female compared with 11% of those in study specialties. No difference was found when comparing the gender of first (P-value = 0.393) and/or last authors (P-value = 0.281) with the proportion of female residents and attendings. CONCLUSIONS: Women surgeons publish research at a rate proportional to the number of females involved in that specialty. Disparities in leadership roles are unlikely explained by differences in publications. Instead, disparities are likely due to other reasons such as failure to attract women to academic surgery and failure to promote and mentor women surgeons into leadership positions.

Lack of Regulations and Conflict of Interest Transparency of New Hernia Surgery Technologies.

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

Are online surgical discussion boards a safe and useful venue for surgeons to ask for advice? A review of the International Hernia Collaboration Facebook Group.

BACKGROUND: Social media is a growing medium for disseminating information among surgeons. The International Hernia Collaboration Facebook Group (IHC) is a widely utilized social media platform to share ideas and advice on managing patients with hernia-related diseases. Our objective was to assess the safety and utility of advice provided. METHODS: Overall, 60 consecutive de-identified clinical threads were extracted from the IHC in reverse chronological order. A group of three hernia specialists evaluated all threads for unsafe posts, unhelpful comments, and if an established evidence-based management strategy was provided. Positive and negative controls for safe and unsafe answers were included in seven threads and reviewers were blinded to their presence. Reviewers were free to access all online and professional resources (except the IHC). RESULTS: There were 598 unique responses (median 10, 1-26 responses per thread) to the 60 clinical threads/scenarios. The review team correctly identified all seven positive and negative controls. Most responses were safe (96.6%) but some were unhelpful (28.4%). For sixteen threads, the reviewers believed there was an established evidence-based answer; however, only six were provided. In addition, 14 responses were considered unsafe, but only four were corrected. CONCLUSIONS: The vast majority of responses were considered helpful; however, evidence-based management is typically not provided and unsafe recommendations often go uncontested. While the IHC allows wide dissemination of hernia-related surgical advice/discussions, surgeons should be cautious when using the IHC for clinical advice. Mechanisms to provide evidence-based management strategies and to identify unsafe advice are needed to improve quality within online forums and to prevent patient harm.

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.

Expectant Management of Patients with Ventral Hernias: 3 Years of Follow-up.

BACKGROUND: The safety and effectiveness of expectant management (e.g., watchful waiting or initially managing non-operatively) for patients with a ventral hernia is unknown. We report our 3-year results of a prospective cohort of patients with ventral hernias who underwent expectant management. METHODS: A hernia clinic at an academic safety-net hospital was used to recruit patients. Any patient undergoing expectant management with symptoms and high-risk comorbidities, as determined by a surgeon based on institutional criteria, would be included in the study. Patients unlikely to complete follow-up assessments were excluded from the study. Patient-reported outcomes were collected by phone and mailed surveys. A modified activities assessment scale normalized to a 1-100 scale was used to measure results. The rate of operative repair was the primary outcome, while secondary outcomes include rate of emergency room (ER) visits and both emergent and elective hernia repairs. RESULTS: Among 128 patients initially enrolled, 84 (65.6%) completed the follow-up at a median (interquartile range) of 34.1 (31, 36.2) months. Overall, 28 (33.3%) patients visited the ER at least once because of their hernia and 31 (36.9%) patients underwent operative management. Seven patients (8.3%) required emergent operative repair. There was no significant change in quality of life for those managed non-operatively; however, substantial improvements in quality of life were observed for patients who underwent operative management. CONCLUSIONS: Expectant management is an effective strategy for patients with ventral hernias and significant comorbid medical conditions. Since the short-term risk of needing emergency hernia repair is moderate, there could be a safe period of time for preoperative optimization and risk-reduction for patients deemed high risk.

The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and complication-free patients. BACKGROUND: Obesity and poor fitness are associated with complications following VHR. These issues are prevalent in low socioeconomic status patients. METHODS: This was a blinded, randomized controlled trial at a safety-net academic institution. Obese patients (BMI 30 to 40) seeking VHR were randomized to prehabilitation versus standard counseling. 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 the proportion of hernia-free and complication-free patients. Secondary outcomes were wound complications at 1 month postoperative and weight loss measures. Univariate analysis was performed. RESULTS: Among 118 randomized patients, prehabilitation was associated with a higher percentage of patients who lost weight and achieved weight loss goals; however, prehabilitation was also associated with a higher dropout rate and need for emergent repair. VHR was performed in 44 prehabilitation and 34 standard counseling patients. There was a trend toward less wound complication in prehabilitation patients (6.8% vs 17.6%, P = 0.167). The prehabilitation group was more likely to be hernia-free and complication-free (69.5% vs 47.5%, P = 0.015). CONCLUSIONS: It is feasible to implement a prehabilitation program for obese patients at a safety-net hospital. Prehabilitation patients have a higher likelihood of being hernia-free and complication-free postoperatively. Although further trials and long-term outcomes are needed, prehabilitation may benefit obese surgical patients, but there may be increased risks of dropout and emergent repair. CLINICAL TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02365194).