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.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

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).

Postoperative Work and Activity Restrictions After Abdominal Surgery: A Systematic Review.

OBJECTIVE: This systematic review aims to assess what is known about convalescence following abdominal surgery. Through a review of the basic science and clinical literature, we explored the effect of physical activity on the healing fascia and the optimal timing for postoperative activity. BACKGROUND: Abdominal surgery confers a 30% risk of incisional hernia development. To mitigate this, surgeons often impose postoperative activity restrictions. However, it is unclear whether this is effective or potentially harmful in preventing hernias. METHODS: We conducted 2 separate systematic reviews using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The first assessed available basic science literature on fascial healing. The second assessed available clinical literature on activity after abdominal surgery. RESULTS: Seven articles met inclusion criteria for the basic science review and 22 for the clinical studies review. The basic science data demonstrated variability in maximal tensile strength and time for fascial healing, in part due to differences in layer of abdominal wall measured. Some animal studies indicated a positive effect of physical activity on the healing wound. Most clinical studies were qualitative, with only 3 randomized controlled trials on this topic. Variability was reported on clinician recommendations, time to return to activity, and factors that influence return to activity. Interventions designed to shorten convalescence demonstrated improvements only in patient-reported symptoms. None reported an association between activity and complications, such as incisional hernia. CONCLUSIONS: This systematic review identified gaps in our understanding of what is best for patients recovering from abdominal surgery. Randomized controlled trials are crucial in safely optimizing the recovery period.

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.

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.

Biologic Versus Synthetic Mesh in Ventral Hernia Repair: Participant-Level Analysis of Two Randomized Controlled Trials at Twenty-Four to Thirty-Six Months.

Background: Biologic mesh has been used increasingly in complex ventral hernia repair despite limited evidence at low risk of bias supporting its use. Patients and Methods: We performed a participant-level analysis of published randomized controlled trials (RCTs) comparing biologic to synthetic mesh with complex ventral hernia repair at 24 to 36 months. Primary outcome was major complication (composite of mesh infection, recurrence, reoperation, or death) at 24 to 36 months post-operative. Secondary outcomes included length of index hospital stay, surgical site occurrence, surgical site infection, and death. Outcomes were assessed using both frequentist and Bayesian generalized linear regression models. Results: A total of 252 patients from two RCTs were included, 126 patients randomized to the intervention arm of biologic and 126 patients to the control of synthetic mesh with median follow-up of 29 (23, 38) months. Major complication occurred in 33 (33%) patients randomized to biologic, and 39 (38%) patients randomized to synthetic mesh, (relative risk [RR] 0.91, 95% confidence interval [CI] 0.63-1.31; p value = 0.600). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had similar probability of major complications at 24 to 36 months post-operative. The remainder of outcomes demonstrated slight benefit with synthetic mesh as opposed to biologic mesh except for mesh infection. However, under a frequentist framework, no outcome was statistically different. Conclusions: In patients undergoing open ventral hernia repair, there was no benefit for patients receiving biologic versus synthetic mesh at 24 to 36 months post-operative.

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.

Systematic Review of Treatment of Patients with Achalasia: Heller Myotomy, Pneumatic Dilation, and Peroral Endoscopic Myotomy.

BACKGROUND: The aim of this systematic review is to assess all comparative randomized controlled trials evaluating Heller myotomy, pneumatic dilation, and peroral endoscopic myotomy. STUDY DESIGN: Achalasia is an esophageal motility disorder associated with degeneration of the myenteric plexus; it causes significant symptoms and impacts patient quality of life (QOL). The optimal treatment for patients with achalasia and the impact of these interventions on QOL remain unclear. PubMed, Embase, Scopus, and Cochrane were searched from inception to April 2020. Randomized controlled trials that compared the 3 interventions were included. Primary outcome was QOL at 12 to 36 months after the operation. Secondary outcomes included reintervention, dysphagia, leak/perforation, and GERD recurrence. RESULTS: Nine publications of 6 studies were included. Of the 9 publications, there was no significant difference in QOL at 12 to 36 months except for one study in which QOL was significantly higher in patients who underwent Heller myotomy as opposed to pneumatic dilation at 3 years; however, at 5 years there was no difference. Pneumatic dilation was associated with the highest rates of dysphagia recurrence and reintervention, but peroral endoscopic myotomy had the lowest. CONCLUSIONS: The treatment of achalasia should be chosen in accordance with patient goals. After any of the 3 interventions, QOL appears to be similar. However, peroral endoscopic myotomy may be associated with the lowest rates of perforation/leak, dysphagia, and reintervention and may be the lowest risk option. However, there are barriers to widespread use due to challenges in training and adoption.

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.

Poor Oral Health in Trauma Intensive Care Unit Patients: Application of a Novel Oral Health Score.

Background: Although oral hygiene in patients in the intensive care unit (ICU) has been shown to reduce hospital-associated infections, baseline and progressive oral health are often not reported because of lack of a standardized tool. The Oral Health Risk Assessment Value Index (OHRAVI) is a comprehensive oral assessment validated by dental providers. This study hypothesizes that non-dental providers can use OHRAVI in trauma ICU patients with minimal training and acceptable inter-rater reliability (IRR). Patients and Methods: Dentulous adult patients in the ICU at a level 1 trauma center were scored, excluding those with severe orofacial trauma. The eight categories of the OHRAVI were scored 0 to 3 (best to worst) with summed total and index (average) score. Index scores 1 or less need routine oral care; greater than 1-2 require moderate care; and greater than 2-3 require extensive oromaxillofacial care. Inter-rater reliability was assessed by two to three raters with Krippendorff's α (≥0.80 for good and ≥0.667 for acceptable). Results: Eighty-four ratings were completed across 34 patients, with 16 patients (47%) scored by all three raters. Ten patients (29%) had an index score <1. The average index score for patients was 1.28 (median, 1.34; range, 0.63-2). Krippendorff's α for index score was 0.86. For individual categories, α ranged from 0.44 to 1, with six of the eight categories achieving an α ≥ 0.667. Conclusions: With minimal training, non-dental providers were able to use OHRAVI with a good IRR for index score and an acceptable/good IRR for most individual categories. This novel, simple, comprehensive oral health score could help standardize oral assessment and facilitate future studies of peri-operative oral hygiene interventions.

Evaluation of ICARUS Guidelines and Recommendations Not Supported by Randomized Controlled Trials.

BACKGROUND: The ICARUS guidelines are a systematic review and Delphi process that provide recommendations in the treatment and management of patients with gastroesophageal reflux disease (GERD). Many of the recommendations were supported by randomized trials; some were not. This study assesses guidelines with limited evidence and weak endorsement. METHODS: Four ICARUS guidelines were chosen: the role of fundoplication for patients with BMI > 35, regurgitation, chest pain, and extra-esophageal symptoms. A multicenter database of patients undergoing fundoplication surgery for GERD between 2015 and 2020 was used. Outcomes assessed were anatomic failure and symptom recurrence. Multivariable regression was performed. RESULTS: Five institutions performed a fundoplication on 461 patients for GERD with a median of follow-up of 14.7 months (IQR 14.2). On multivariate analysis, patients with the chosen pre-operative comorbidities achieved comparable post-operative benefits. Patients with a BMI > 35 were not more likely to experience anatomic failure. Patients with pre-operative regurgitation had similar symptom recurrence rates to those without. Patients with non-cardiac chest pain had comparable rates of symptom recurrence to those without. Reporting a pre-operative chronic cough attributable to reflux was not associated with higher rates of post-operative symptom recurrence. DISCUSSION: Among the ICARUS guidelines and recommendations, a small proportion was lacking evidence at low risk for bias and endorsement. The results of this multicenter study evaluated outcomes of patients with various pre-operative conditions: BMI > 35, chest pain attributable to reflux, extra-esophageal symptoms attributable to reflux, and regurgitation. Our findings endorse patients with these characteristics as candidates for anti-reflux surgery.