Randomized Controlled Trial Based US Commercial Payor Cost-Effectiveness Analysis of Endoscopic Sleeve Gastroplasty Versus Lifestyle Modification Alone for Adults With Class I/II Obesity.

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive day procedure that the MERIT randomized controlled trial (RCT) has demonstrated to be an effective and safe method of weight loss versus lifestyle modification alone. We sought to evaluate the cost-effectiveness of ESG from the perspective of a US commercial payer in a cohort of adults with class II and class I obesity with diabetes based on this RCT. MATERIALS: We used a Markov modelling approach with BMI group health states and an absorbing death state. Baseline characteristics, utilities, BMI group transition probabilities, and adverse events (AEs) were informed by patient-level data from the MERIT RCT. Mortality was estimated by applying BMI-specific hazard ratios to US general population mortality rates. We used BMI-based health state utilities to reflect the impact of obesity comorbidities and applied disutilities due to ESG AEs. Costs included intervention costs, AE costs, and BMI-based annual direct healthcare costs to account for costs associated with obesity comorbidities. A willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was assumed. RESULTS: In our base-case analysis over a 5-year time horizon, ESG was cost-effective versus lifestyle modification alone with an incremental cost-effectiveness ratio of $23,432/QALY. ESG remained cost-effective in all sensitivity analyses we conducted and was dominant in analyses with longer time horizons. CONCLUSION: ESG is a cost-effective treatment option for people living with obesity and should be considered in commercial health plans as an additional treatment option for clinically eligible patients.

Frequency of Clinically Significant Findings in the Surgical Pathology Specimen Following Laparoscopic Sleeve Gastrectomy and Concordance with Preoperative Endoscopy: Insights from a Large Single-Center Experience.

INTRODUCTION: Endoscopy prior to bariatric surgery is not always performed, and in sleeve gastrectomy (SG), the surgical specimen is not always sent for pathological examination. There is limited data on the frequency of clinically significant findings in SG specimens or correlation with preoperative endoscopy. METHODS: We reviewed 426 consecutive SG patients to determine the concordance of preoperative endoscopy findings in patients with clinically significant postoperative pathology. RESULTS: Preoperative endoscopy was performed on 397 patients (93.2%). Three hundred seventy-three patients had preoperative endoscopy and surgical pathology results available. Then, 20/373 (5.4%) patients had potentially significant postoperative pathology, including intestinal metaplasia, autoimmune metaplastic atrophic gastritis (AMAG), gastrointestinal stromal tumors, and/or gastric cancer. The overall incidence of AMAG in the entire cohort was 2.3%. Preoperative gastric biopsies (to include gastric body) identified AMAG in nearly 1/2 of patients. Patients with clinically significant postoperative pathology results had a median [interquartile range] of 3 [3-5] tissue blocks examined as compared to 3 [1-3] for the remainder of the cohort (p < 0.001). CONCLUSION: This is one of the largest studies describing clinically significant postoperative pathology after SG. AMAG, in particular, is of particular importance as it is associated with a 3-fivefold increase in risk for gastric cancer. The incidence of significant postoperative pathology in this population is small but potentially clinically significant and requires validation in larger studies. We recommend wider sampling in preoperative endoscopy (body and antrum), especially in patients being planned for gastric bypass, consideration for routine pathological examination of SG surgical specimens, with careful gross examination and targeted sampling.

Practice patterns and outcomes of endoscopic sleeve gastroplasty based on provider specialty.

Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

Global benchmarks in primary robotic bariatric surgery redefine quality standards for Roux-en-Y gastric bypass and sleeve gastrectomy.

BACKGROUND: Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks. METHODS: Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50 kg/m2, or age greater than 65 years. RESULTS: A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42 min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass. CONCLUSION: The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer.

Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: A retrospective study.

Background and study aims Concomitant hiatal hernia (HH) repair with transoral incisionless fundoplication (TIF) is a therapeutic option for patients with HH > 2 cm and gastroesophageal reflux disease (GERD). Data comparing this approach with laparoscopic Nissen fundoplication (LNF) are lacking. We performed an exploratory analysis to compare these two approaches' adverse events (AEs) and clinical outcomes. Patients and methods This was a multicenter retrospective cohort study of HH repair followed by LNF versus HH repair followed by TIF in patients with GERD and moderate HH (2-5 cm). AEs were assessed using the Clavien-Dindo classification. Symptoms (heartburn/regurgitation, bloating, and dysphagia) were compared at 6 and 12 months. Results A total of 125 patients with HH repair with TIF and 70 with HH repair with LNF were compared. There was no difference in rates of discontinuing or decreasing proton pump inhibitor use, dysphagia, esophagitis, disrupted wrap, and HH recurrence between the two groups ( P  > 0.05). The length of hospital stay (1 day vs. 2 days), 30-day readmission rate (0 vs. 4.3 %), early AE rate (0 vs. 18.6 %), and early serious AE rate (0 vs. 4.3 %) favored TIF (all P  < 0.05). The rate of new or worse than baseline bloating was lower in the TIF group at 6 months (13.8 % vs. 30.0 %, P  = 0.009). Conclusions Concomitant HH repair with TIF is feasible and associated with lower early and serious AEs compared to LNF. Further comparative efficacy studies are warranted.

Assessment of predictors of early postoperative complications after primary robotically assisted Roux-en-Y gastric bypass: a multicenter, retrospective cohort study.

BACKGROUND: Robotic Roux-en-Y gastric bypass (RRYGB) is performed in an increasing number of bariatric centers worldwide. Previous studies have identified a number of demographic and clinical variables as predictors of postoperative complications after laparoscopic Roux-en-Y gastric bypass (LRYGB). Some authors have suggested better early postoperative outcomes after RRYGB compared to LRYGB. The objective of the present study was to assess potential predictors of early postoperative complications after RRYGB. METHODS: A retrospective analysis of two prospective databases containing patients who underwent RRYGB between 2006 and 2019 at two high volumes, accredited bariatric centers was performed. Primary outcome was rate of 30 day postoperative complications. Relevant demographic, clinical and biological variables were entered in a multivariate, logistic regression analysis to identify potential predictors. RESULTS: Data of 1276 patients were analyzed, including 958 female and 318 male patients. Rates of overall and severe 30 day complications were 12.5% (160/1276) and 3.9% (50/1276), respectively. Rate of 30 day reoperations was 1.6% (21/1276). The overall gastrointestinal leak rate was 0.2% (3/1276). Among various demographic, clinical and biological variables, male sex and ASA score >2 were significantly correlated with an increased risk of 30 day complication rates on multivariate analysis (OR 1.68 and 1.67, p=0.005 and 0.005, respectively). CONCLUSION: This study identified male sex and ASA score >2 as independent predictors of early postoperative complications after RRYGB. These data suggest a potentially different risk profile in terms of early postoperative complications after RRYGB compared to LYRGB. The robotic approach might have a benefit for patients traditionally considered to be at higher risk of complications after LRYGB, such as those with BMI >50. The present study was however not designed to assess this hypothesis and larger, prospective studies are necessary to confirm these results.

Utility and usability of laser speckle contrast imaging (LSCI) for displaying real-time tissue perfusion/blood flow in robot-assisted surgery (RAS): comparison to indocyanine green (ICG) and use in laparoscopic surgery.

BACKGROUND: Utility and usability of laser speckle contrast imaging (LSCI) in detecting real-time tissue perfusion in robot-assisted surgery (RAS) and laparoscopic surgery are not known. LSCI displays a color heatmap of real-time tissue blood flow by capturing the interference of coherent laser light on red blood cells. LSCI has advantages in perfusion visualization over indocyanine green imaging (ICG) including repeat use on demand, no need for dye, and no latency between injection and display. Herein, we report the first-in-human clinical comparison of a novel device combining proprietary LSCI processing and ICG for real-time perfusion assessment during RAS and laparoscopic surgeries. METHODS: ActivSight™ imaging module is integrated between a standard laparoscopic camera and scope, capable of detecting tissue blood flow via LSCI and ICG in laparoscopic surgery. From November 2020 to July 2021, we studied its use during elective robotic-assisted and laparoscopic cholecystectomies, colorectal, and bariatric surgeries (NCT# 04633512). For RAS, an ancillary laparoscope with ActivSight imaging module was used for LSCI/ICG visualization. We determined safety, usability, and utility of LSCI in RAS vs. laparoscopic surgery using end-user/surgeon human factor testing (Likert scale 1-5) and compared results with two-tailed t tests. RESULTS: 67 patients were included in the study-40 (60%) RAS vs. 27 (40%) laparoscopic surgeries. Patient demographics were similar in both groups. No adverse events to patients and surgeons were observed in both laparoscopic and RAS groups. Use of an ancillary laparoscopic system for LSCI/ICG visualization had minimal impact on usability in RAS as evidenced by surgeon ratings of device usability (set-up 4.2/5 and form-factor 3.8/5). LSCI ability to detect perfusion (97.5% in RAS vs 100% in laparoscopic cases) was comparable in both RAS and laparoscopic cases. CONCLUSIONS: LSCI demonstrates comparable utility and usability in detecting real-time tissue perfusion/blood flow in RAS and laparoscopic surgery.

The rising tide of revisional surgery: tracking changes in index cases among bariatric-accredited fellowships.

BACKGROUND: The field of bariatric surgery has seen peaks and troughs in the types of metabolic procedures performed. Our primary aim was to evaluate bariatric case volumes among fellows enrolled in bariatric Fellowship Council (FC)-accredited programs. Our secondary aim was to assess trends in revisional case volumes. METHODS: We reviewed de-identified FC case logs for all bariatric surgery-accredited programs from 2010 through 2019. The number of primary sleeve gastrectomy, gastric band, gastric bypass, biliopancreatic diversion, and major revisional bariatric surgical procedures (defined as a revision with creation of a new anastomosis) were graphed for each academic year. Fellows were stratified into quartiles based on the number of revisional operations per year and graphed over ten years. Volumes of primary gastric bypass, major revisions, and total anastomotic cases were compared over time using ANOVA with p < 0.05 considered significant. RESULTS: Case volumes for 822 fellows were evaluated. Sleeve gastrectomy had a significant surge in 2010 and plateaued in 2016. The fellows' number of primary gastric bypasses had a non-significant decrease from 84 to 75 cases/fellow from 2010 to 2019. This decrease was offset by a significant increase in major revisional surgery from 8 to 19 cases/fellow. As a result, the number of anastomotic cases did not change significantly over the study time period. Interestingly, as revisional volume has grown, the gap between quartiles of fellowship programs has widened with the 95th percentile growing at a much faster rate than lower quartiles. CONCLUSION: The volume of bariatric procedures performed in the last decade among FC fellows follows similar trends to national data. Major revisional cases have doubled with the most robust growth isolated to a small number of programs. As revisional surgery continues to increase, applicants interested in a comprehensive bariatric practice should seek out training programs that offer strong revisional experience.

Palliative Endoscopic Salvage of a Functionally Obstructed Gastrojejunostomy - Report of Technique.

Background: Gastric outlet obstruction secondary to foregut gastrointestinal malignancies can be managed with a variety of medical, endoscopic, and surgical options. Laparoscopic gastrojejunostomy is an option for those patients who are able to tolerate an operation as a long-term palliative option. This operation may be associated with some significant postoperative technical and nontechnical complications, including delayed gastric emptying. This paper describes an incision-less, endoscopic option that we propose can be used to salvage a functionally obstructed gastrojejunostomy. Case Description: A 57-year old male patient had a history of pancreatic adenocarcinoma causing gastric outlet obstruction and underwent a previously created surgical gastrojejunostomy at an outside hospital. His procedure was complicated by anastomotic leak and essentially persistent obstructive symptoms secondary to delayed gastric emptying. Though his anastomosis was demonstrably patent, these symptoms were thought to be secondary to a functional obstruction at the gastrojejunostomy. After repeated workups and many failed attempts to treat these symptoms, he ultimately underwent endoscopic placement of an uncovered colonic stent into the efferent limb of his gastrojejunostomy. This allowed for preferential drainage of gastric contents down the efferent limb, and improvement of his delayed gastric emptying. Conclusions: In a select group of patients with advanced foregut malignancy, and with high re-operative risks, salvage endoscopic stenting may be useful in the palliation of symptoms from a functionally obstructed gastrojejunostomy.

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.

Thromboelastography-Based Profiling of Coagulation Status in Patients Undergoing Bariatric Surgery: Analysis of 422 Patients.

INTRODUCTION/PURPOSE: Some clinical indicators suggest hypercoagulability/hyperaggregability in patients with morbid obesity. Thromboelastography (TEG®) has been used to profile coagulation status in surgical patients. We aimed to assess coagulation profiles in patients with morbid obesity undergoing bariatric surgery by correlating demographic and patient characteristics to pre-operative TEG® values. MATERIALS AND METHODS: Pre-operative TEG® values from 422 patients undergoing bariatric surgery were evaluated. TEG® results were analyzed by gender, use of medications known to alter the coagulation profile, and body mass index (BMI). RESULTS: Patients have a mean of 45.03 ± 11.8 years, female (76.3%), and with a mean BMI of 42 kg/m 1. The overall coagulation profile of female patients was significantly different from males, even in the sub-cohort without use of medications known to alter coagulation. The majority of patients (94%) with a G value > 15 dynes/cm 1 (clot strength) were female. In females, there was no association between BMI and TEG® values; however, in men, there was a statistically significant difference in TEG® values for those with BMI < 40 kg/m 1 compared to those with BMI > 50 kg/m2. CONCLUSIONS: TEG®-based analysis of coagulation profiles offers unique insights. Compared to laboratory normal values (R time, angle, maximal amplitude, and G values), patients with morbid obesity may have a tendency for hypercoagulability/hyperaggregability, with mean values at the higher limit. A significant hypercoagulable difference in TEG® values was identified in female as compared to male patients. Male patients with a BMI greater than 50 kg/m2 were also found to be increasingly hypercoagulable.

Outcomes of primary versus revisional robotically assisted laparoscopic Roux-en-Y gastric bypass: a multicenter analysis of ten-year experience.

BACKGROUND: Postoperative morbidity after laparoscopic bariatric surgery is considered higher for patients undergoing revisional versus primary procedures. The objective of this retrospective cohort study was to compare outcomes between patients undergoing primary versus revisional robotically assisted laparoscopic (RAL) Roux-en-Y gastric bypass (RYGB). METHODS: Data of all patients who underwent RAL primary and revisional RYGB between 2009 and 2019 at two accredited, high-volume bariatric surgery centers-the Memorial Hermann - Texas Medical Center, Houston, TX, and the Tower Health, Reading Hospital, Reading, PA, were analyzed. Primary outcomes were early (< 30 days) and overall postoperative complications. Secondary outcomes included intraoperative complications, operative times, conversions to laparotomy, length of hospital stay, early (< 30 days) postoperative readmissions and deaths. RESULTS: Data of 1072 patients were analyzed, including 806 primary and 266 revisional RAL RYGB procedures. Longer operative times (203 versus 154 min, P < 0.001), increased number of readmissions for oral intolerance (10.5% versus 6.7%, P = 0.046) and higher rate of gastrojejunal stricture (6.4% versus 2.7%, P = 0.013) were found in the revisional group. Gastrointestinal leak rates were 0.2% for the primary versus 1.1% for the revisional group (P = 0.101). Early (< 30 days) reoperations rates were 2.2% for the primary versus 1.1% for the revisional group (P = 0.318). There were no statistically significant differences between groups in overall and severe complication rates. CONCLUSION: Patients undergoing RAL primary and revisional RYGB had comparable overall outcomes, with a non-significant higher early complication rate in the revisional group. Despite the study being underpowered to detect differences in specific complication rates, the morbidity seen in the revisional RYGB group remains markedly below literature reports of revisional laparoscopic RYGB and might suggest a benefit of robotic assistance. Further prospective studies are needed to confirm these results.

Management of Acute Gastric Remnant Complications After Roux-en-Y Gastric Bypass: a Single-Center Case Series.

PURPOSE: Roux-en-Y gastric bypass is a common bariatric procedure. Its configuration creates an excluded gastric remnant, which is subject to potential acute complications such as bleeding, perforation, and necrosis. MATERIAL AND METHODS: A retrospective analysis of a prospective database including all patients presenting between 2007 and 2019 to our institution with acute gastric remnant complications after RYGB was performed. RESULTS: Seven patients were included, including 3 hemorrhages, two of which were treated with double-balloon enteroscopy, as well as 3 perforations and 1 necrosis, all of which required emergent surgery. Overall gastric remnant complication rate was 0.3% in this series. CONCLUSION: Acute gastric remnant complications after RYGB are infrequent, but their diagnosis and management can be challenging. Double-balloon enteroscopy has diagnostic and therapeutic value for selected patients. Emergent surgery remains the standard of care for unstable patients and should not be delayed.

Robotic Primary and Revisional Bariatric Surgery.

In this article, we review the role of robotics in bariatric surgery. After a brief overview of the evolution of minimally invasive bariatric surgery, we discuss possible advantages of robotic systems and subsequently go into more details about each procedure, including adjustable gastric bands, sleeve gastrectomy, Roux-en-Y gastric bypass, and biliopancreatic diversion with duodenal switch. We also discuss outcomes of robotics in reoperative bariatric surgery. Considerations about training are presented as well.

Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.

BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.

Safety of robotic assisted laparoscopic recurrent paraesophageal hernia repair: insights from a large single institution experience.

BACKGROUND: Laparoscopic repair of recurrent as opposed to primary paraesophageal hernias (PEHs) are historically associated with increased peri-operative complication rates, worsened outcomes, and increased conversion rates. The robotic platform may aid surgeons in these complex revision procedures. The aim of this study was to compare the outcomes of patients undergoing robotic assisted laparoscopic (RAL) repair of recurrent as opposed to primary PEHs. METHODS: Patients undergoing RAL primary and recurrent PEH repairs from 2009 to 2017 at a single institution were reviewed. Demographics, use of mesh, estimated blood loss, intra-operative complications, conversion rates, operative time, rates of esophageal/gastric injury, hospital length of stay, re-admission/re-operation rates, recurrence, dysphagia, gas bloat, and pre- and post-operative proton pump inhibitor (PPI) use were analyzed. Analysis was accomplished using Chi-square test/Fischer's exact test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: There were 298 patients who underwent RAL PEH repairs (247 primary, 51 recurrent). They were followed for a median (interquartile range) of 120 (44, 470) days. There were no significant differences in baseline demographics between groups. Patients in the recurrent PEH group had longer operative times, increased use of mesh, and increased length of hospital stay. They were also less likely to undergo fundoplication. There were no significant differences in estimated blood loss, incidence of intra-operative complications, re-admission rates, incidence of post-operative dysphagia and gas bloat, and incidence of post-operative PPI use. There were no conversions to open operative intervention or gastric/esophageal injury/leaks. CONCLUSIONS: Although repair of recurrent PEHs are historically associated with worse outcomes, in this series, RAL recurrent PEH repairs have similar peri-operative and post-operative outcomes as compared to primary PEH repairs. Whether this is secondary to the potential advantages afforded by the robotic platform deserves further study.

Trocar site closure with a novel anchor-based (neoClose®) system versus standard suture closure: a prospective randomized controlled trial.

BACKGROUND: Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery. METHODS: This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia. RESULTS: The use of the neoClose® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group. CONCLUSIONS: Use of the neoClose® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.