Effectiveness of bedside staplers in bariatric robotic procedures.

BACKGROUND: Few studies have evaluated the use of laparoscopic staplers in robotic procedures (bedside stapling, BS). This study aims to evaluate the effectiveness of BS compared with robotic staplers (RS) in bariatric robotic procedures. METHODS: Patients who underwent robotic sleeve gastrectomy or gastric bypass elective procedures between 1/1/2021 and 12/31/2021 were extracted from PINC AI™ Healthcare Data. The following clinical outcomes were compared: blood transfusion, bleeding, anastomotic leak, intensive care unit (ICU) visit, and 30-day readmission, operating room (OR) time, inpatient costs, and length of stay. We evaluated baseline balance in BS and RS and bivariate association between covariates and outcomes using Chi-square or Fisher exact test and t-test or ANOVA. Multivariable general linear mixed models (GLMMs) with respective gamma or binomial distribution and log-link function were used to obtain adjusted outcomes variations between BS and RS. RESULTS: Total of 7268 discharges were included with 1603 (22.1%) BS and 5665 (77.9%) RS cases. RS cases consisted of a higher number of patients who were Hispanic (17.0% vs. 9.4%), had Medicaid (26.9% vs. 19.4%) and underwent sleeve gastrectomy (68.4% vs. 53.5%). Higher proportions of RS cases were done by providers in Northeast region (35.5% vs. 24.3%), smaller size (< 500 beds; 71.1% vs. 52.3%), and teaching hospitals (59.4% vs. 39%). The adjusted outcomes variations demonstrated that patients that had RS were significantly more likely to have blood transfusions, ICU stays, increased ORT (19 min) and costs ($1273). Sensitivity analysis showed similar results, except no significant differences in blood transfusion rates in both groups. CONCLUSIONS: Bedside staplers significantly reduce healthcare resource utilization with equivalent effectiveness and fewer ICU stays compared to robotic staplers.

Single-Port Sleeve Gastrectomy Compared With Conventional Laparoscopic Sleeve Gastrectomy: 5-Year Follow-up of Weight Loss, Comorbidity Resolution, and Cost.

Background. The Single-Port Instrument Delivery Extended Reach (SPIDER) surgical system is a safe revolutionary technology that defeated difficulties of single-incision surgery. We assessed the long-term outcomes of SPIDER sleeve gastrectomy (SPIDER SG) versus conventional laparoscopic sleeve gastrectomy (LSG) in morbidly obese patients. Methods. Retrospective review of patients who underwent SPIDER SG or LSG in our center matched by the date of surgery (2012-2013). We reviewed weight loss results up to 5 years, complication rates, procedure and hospitalization durations, financial cost, and effect on comorbidities. Results. Patients underwent 200 SPIDER SG and 220 LSG. At baseline, SPIDER SG versus LSG patients had a mean body mass index of 43.8 ± 5.6 and 48.6 ± 8.1 kg/m2, respectively. At 1 year, both groups had comparable percentage of excess weight loss (%EWL). At 5 years, SPIDER SG had %EWL of 54.6 ± 24.8 compared with 57.8 ± 29.9 in LSG (P = .4). Nine SPIDER SG (4.5%) required conversion to LSG. Complications occurred in both groups: 4% versus 4.1% (P = .95). At 2-year follow-up, diabetes mellitus was reversed in 43% of SPIDER SG and 62% LSG. Despite a shorter hospital stay in SPIDER SG, the total cost was significantly higher ($2 041 477) compared with LSG ($1 773 834). The mean score of scar satisfaction was significantly more in SPIDER SG. Conclusions. SPIDER SG was safe with long-term effects on weight loss comparable to LSG. Despite the higher cost of SPIDER SG, a shorter hospital stay and better cosmesis were observed.

Metabolic and Bariatric Surgeon Criteria-An International Experts' Consensus.

PURPOSE: With the global epidemic of obesity, the importance of metabolic and bariatric surgery (MBS) is greater than ever before. Performing these surgeries requires academic training and the completion of a dedicated fellowship training program. This study aimed to develop guidelines based on expert consensus using a modified Delphi method to create the criteria for metabolic and bariatric surgeons that must be mastered before obtaining privileges to perform MBS. METHODS: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database. CONCLUSION: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies.

Revision/Conversion Surgeries After One Anastomosis Gastric Bypass-An Experts' Modified Delphi Consensus.

PURPOSE: There is a lack of evidence for treatment of some conditions including complication management, suboptimal initial weight loss, recurrent weight gain, or worsening of a significant obesity complication after one anastomosis gastric bypass (OAGB). This study was designed to respond to the existing lack of agreement and to provide a valuable resource for clinicians by employing an expert-modified Delphi consensus method. METHODS: Forty-eight recognized bariatric surgeons from 28 countries participated in the modified Delphi consensus to vote on 64 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: A consensus was achieved for 46 statements. For recurrent weight gain or worsening of a significant obesity complication after OAGB, more than 85% of experts reached a consensus that elongation of the biliopancreatic limb (BPL) is an acceptable option and the total bowel length measurement is mandatory during BPL elongation to preserve at least 300-400 cm of common channel limb length to avoid nutritional deficiencies. Also, more than 85% of experts reached a consensus on conversion to Roux-en-Y gastric bypass (RYGB) with or without pouch downsizing as an acceptable option for the treatment of persistent bile reflux after OAGB and recommend detecting and repairing any size of hiatal hernia during conversion to RYGB. CONCLUSION: While the experts reached a consensus on several aspects regarding revision/conversion surgeries after OAGB, there are still lingering areas of disagreement. This highlights the importance of conducting further studies in the future to address these unresolved issues.

Current recommendations for procedure selection in class I and II obesity developed by an expert modified Delphi consensus.

Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2. Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future.

One Anastomosis Gastric Bypass Versus Single Anastomosis Duodenoileostomy with Sleeve: Comparative Analysis of 30-Day Outcomes Using the MBSAQIP.

INTRODUCTION/PURPOSE: One anastomosis gastric bypass (OAGB) and single anastomosis duodenoileostomy with sleeve (SADI-S) are two highly effective bariatric procedures that have been recently endorsed by the American Society of Metabolic and Bariatric Surgery (ASMBS). We compared the outcomes and safety profiles of SADI-S and OAGB using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. MATERIALS AND METHODS: Retrospective analysis on patients who underwent SADI-S or OAGB obtained from the MBSAQIP database 2020-2021. Patients who underwent concurrent procedures (besides EGD) or had missing data were removed. Variables included age, sex, body mass index, American Society of Anesthesiologists (ASA) class, and pertinent medical comorbidities. Data were analyzed for 30-day postoperative morbidity, mortality, reoperation, reintervention, and readmissions. p values were calculated using Student's t-test or Fisher analysis. RESULTS: A total of 694 and 1068 patients respectively underwent SADI-S or OAGB. Statistically significant comorbidities included age (42.2 ± 10.8 vs. 43.7 ± 12.2), BMI (50.6 ± 9.1 vs. 45.3 ± 7.1), ASA 2 (66 (9.5%) vs. 165 (15.4%)), ASA 4 [69 (9.9%) vs. 20 (1.9%)], and immunosuppressive therapy [24 (3.5%) vs. 17 (1.6%)]. Clavien-Dindo-based analysis highlighted that SADI-S had higher grade 2 (p = 0.005) and grade 4b (p = 0.001) complications. Patients who underwent SADI-S were twice as likely to be readmitted within 30 days (3.7% vs. 1.9%; p = 0.021). CONCLUSION: SADI-S had higher readmission rates and higher Clavien-Dindo grade 2 and 4b complications. To note, SADI-S patients had higher BMIs. Further studies are needed to determine the long-term complications and efficacy of both operations.

Bariatric Evaluation Through AI: a Survey of Expert Opinions Versus ChatGPT-4 (BETA-SEOV).

BACKGROUND: Recent advancements in artificial intelligence, such as OpenAI's ChatGPT-4, are revolutionizing various sectors, including healthcare. This study investigates the use of ChatGPT-4 in identifying suitable candidates for bariatric surgery and providing surgical recommendations to improve decision-making in obesity treatment amid the global obesity epidemic. METHODS: We devised ten patient scenarios, thoughtfully encompassing a spectrum that spans from uncomplicated cases to more complex ones. Our objective was to delve into the decision-making process regarding the recommendation of bariatric surgery. From July 29th to August 10th, 2023, we conducted a voluntary online survey involving thirty prominent bariatric surgeons, ensuring that there was no predetermined bias in the selection of a specific type of bariatric surgery. This survey was designed to collect their insights on these scenarios and gain a deeper understanding of their professional experience and background in the field of bariatric surgery. Additionally, we consulted ChatGPT-4 in two separate conversations to evaluate its alignment with expert opinions on bariatric surgery options. RESULTS: In 40% of the scenarios, disparities were identified between the two conversations with ChatGPT-4. It matched expert opinions in 30% of cases. Differences were noted in cases like gastrointestinal metaplasia and gastric adenocarcinoma, but there was alignment with conditions like endometriosis and GERD. CONCLUSION: The evaluation of ChatGPT-4's role in determining bariatric surgery suitability uncovered both potential and shortcomings. Its alignment with experts was inconsistent, and it often overlooked key factors, emphasizing human expertise's value. Its current use requires caution, and further refinement is needed for clinical application.

Bile Reflux After Single Anastomosis Duodenal-Ileal Bypass with Sleeve (SADI-S): a Meta-analysis of 2,029 Patients.

BACKGROUND: Single anastomosis duodenal-ileal bypass with sleeve (SADI-S) is a novel bariatric surgery modified from the classic biliopancreatic diversion with duodenal switch (BPD-DS). These surgical modifications address most BPD-DS hurdles, but the risk of bile reflux may hinder SADI-S acceptance. We aimed to evaluate the event rate of bile reflux after SADI-S. METHODS: PubMed, ScienceDirect, Cochrane, Web of Science, and Google Scholar were used to search English articles between 2008 and 2021 by two independent reviewers using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA). The risk of bias was assessed using Newcastle-Ottawa Scale and the JBI tool. Event rates were meta-analyzed using Comprehensive Meta-Analysis (CME) V3. RESULTS: Out of 3,027 studies analyzed, seven were included. Studies were published between 2010 and 2020. Six out of 7 studies were retrospective. Three studies had a low risk of bias, three studies had a moderate risk of bias, and one had a high risk of bias. The mean follow-up was 10.3 months. The total number of patients was 2,029, with 25 reports of bile reflux, resulting in an incidence of 1.23%, with an event rate of 0.016 (95% CI 0.004 to 0.055). CONCLUSIONS: Bile reflux has not been demonstrated to be problematic after SADI-S in this meta-analysis. Further long-term studies are needed.

Patient Selection in One Anastomosis/Mini Gastric Bypass-an Expert Modified Delphi Consensus.

PURPOSE: One anastomosis/mini gastric bypass (OAGB/MGB) is up to date the third most performed obesity and metabolic procedure worldwide, which recently has been endorsed by ASMBS. The main criticisms are the risk of bile reflux, esophageal cancer, and malnutrition. Although IFSO has recognized this procedure, guidance is needed regarding selection criteria. To give clinicians a daily support in performing the right patient selection in OAGB/MGB, the aim of this paper is to generate clinical guidelines based on an expert modified Delphi consensus. METHODS: A committee of 57 recognized bariatric surgeons from 24 countries created 69 statements. Modified Delphi consensus voting was performed in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was considered to indicate a consensus. RESULTS: Consensus was achieved for 56 statements. Remarkably, ≥ 90.0% of the experts felt that OAGB/MGB is an acceptable and suitable option "in patients with Body mass index (BMI) > 70, BMI > 60, BMI > 50 kg/m2 as a one-stage procedure," "as the second stage of a two-stage bariatric surgery after Sleeve Gastrectomy for BMI > 50 kg/m2 (instead of BPD/DS)," and "in patients with weight regain after restrictive procedures. No consensus was reached on the statement that OAGB/MGB is a suitable option in case of resistant Helicobacter pylori. This is likely as there is a concern that this procedure is associated with reflux and its related long-term complications including risk of cancer in the esophagus or stomach. Also no consensus reached on OAGB/MGB as conversional surgery in patients with GERD after restrictive procedures. Consensus for disagreement was predominantly achieved "in case of intestinal metaplasia of the stomach" (74.55%), "in patients with severe Gastro Esophageal Reflux Disease (GERD)(C,D)" (75.44%), "in patients with Barrett's metaplasia" (89.29%), and "in documented insulinoma" (89.47%). CONCLUSION: Patient selection in OAGB/MGB is still a point of discussion among experts. There was consensus that OAGB/MGB is a suitable option in elderly patients, patients with low BMI (30-35 kg/m2) with associated metabolic problems, and patients with BMIs more than 50 kg/m2 as one-stage procedure. OAGB/MGB can also be a safe procedure in vegetarian and vegan patients. Although OAGB/MGB can be a suitable procedure in patients with large hiatal hernia with concurrent hiatal hernia, it should not be offered to patients with grade C or D esophagitis or Barrett's metaplasia.

Weight Loss Outcomes of Laparoscopic Adjustable Gastric Band with Plication: a Single Center Experience of 66 Patients with 18-Month Follow-Up.

BACKGROUND: Laparoscopic adjustable gastric band with plication (LAGBP) is a novel bariatric procedure, which combines the adjustability of the laparoscopic adjustable gastric band (LAGB) with the restrictive nature of the vertical sleeve gastrectomy (VSG). The addition of plication of the stomach to LAGB should provide better appetite control, more effective weight loss, and greater weight loss potential. The purpose of the study was to analyze the outcomes of LAGBP at 18 months. METHODS: Data from all patients who underwent a primary LAGBP procedure from December 2011 through June 2016 were retrospectively analyzed. Data collected from each patient included age, gender, weight, body mass index (BMI), and excess weight loss (EWL). RESULTS: Sixty-six patients underwent LAGBP. The mean age and BMI were 44.6 ± 12.7 years and 42.1 ± 5.1 kg/m2, respectively. The patients lost an average of 49% and 46.8% EWL at 12 months (77.2% follow-up) and 18 months (66.1% follow-up), respectively. The mean band adjustments were 2.1 ± 1.7 (range, 0-7) per patient in 1 year. The mean additional adjustment volume (infusion and withdrawal of saline) was 0.6 ± 1 cc. Dysphagia was the most common long-term complication. The band removal rate was 7.5%. The mortality rate was 0%. CONCLUSIONS: LAGBP is a relatively safe and effective bariatric procedure. In light of recent studies demonstrating poor outcomes following LAGB, LAGBP may prove to be the future for patients desiring a bariatric procedure without resection of the stomach.

A Multi-institutional Study on the Mid-Term Outcomes of Single Anastomosis Duodeno-Ileal Bypass as a Surgical Revision Option After Sleeve Gastrectomy.

INTRODUCTION: Recently, a single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has become increasingly popular for patients with BMI > 50 as a primary or staged surgery. Staging allows surgeons to do the sleeve gastrectomy (SG) first with the conversion only happening when a failure or technical challenge is identified. PURPOSE: We present the mid-term outcomes of SADI bypass surgery after SG. METHOD: A retrospective analysis was performed on a prospective database from four institutions. Ninety-six patients were identified from 2013 to 2018. Patients were divided into two groups: one had two-stage SADI because of insufficient weight loss, the second had planned two-stage SADI because of super obesity (BMI > 50 kg/m2). Incidence of complications was divided into < 30 days and > 30 days. RESULT: Of 96 patients, 3 patients were completely lost to follow-up. The mean age was 44.8 ± 11.3 years. There were no deaths or conversion to open surgery. The postoperative early complication and late complication rate was 5.3% and 6.4% respectively. At 24 months, group 2 had higher %weight loss (WL) and change in BMI units compared to group 1 with statistically significant difference. The average WL and change in BMI for entire patient's population at 24 months after 2nd stage SADI was 20.5% and 9.4 units respectively. The remission rate for DM was 93.7% with or without the use of medication. CONCLUSION: The two-stage approach to SADI-S appears technically simpler than a single compromised operation. However, this approach needs more patients to understand its limitations.

Quality of life after laparoscopic adjustable gastric banding (LAP-BAND): APEX interim 3-year analysis.

BACKGROUND: Obesity is often associated with diminished health-related quality of life (HRQOL), but significant gains in HRQOL have been observed after bariatric surgery. Laparoscopic adjustable gastric banding has been established as a safe, effective treatment to reduce weight in patients with obesity. This report summarizes interim 3-year changes in HRQOL and body weight, as well as safety postimplantation of the LAP-BAND AP (LBAP) system. METHODS: The LAP-BAND AP EXperience (APEX) trial, an ongoing, prospective, 5-year, open-label study, assessed changes in HRQOL (Obesity and Weight-Loss Quality of Life [OWLQOL] questionnaire) and body weight, and safety after placement of LBAP. This interim analysis represents patients with evaluable OWLQOL data at baseline and at 3 years (n = 183). RESULTS: The OWLQOL total score and individual scores significantly improved within 6 months post-LBAP and continued to improve during a 3 year period (P < 0.0001, both). Total score improved from 71.0 to 34.0 (mean improvement from baseline, 52%; range, 18%-65%); mean change in individual scores was -2.2 (range, -0.7 to -3.0). Percent weight loss was maintained through 3 years (19.4%; n = 174). Improvement in OWLQOL was associated with percent weight loss at 3 years (r = -0.5407; P < 0.0001). Revisions and explants were performed in 7 (3.8%) and 20 (10.9%) out of 183 patients, respectively. CONCLUSIONS: Meaningful improvement in quality of life occurred through clinically significant weight loss after LBAP placement, extending throughout the 3 years of this analysis.

Effect of early weight loss on type 2 diabetes mellitus after 2 years of gastric banding.

OBJECTIVE: Laparoscopic adjustable gastric banding (LAGB) is an established bariatric surgical procedure that produces meaningful weight loss and improvements in patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) ≥ 30 kg/m2. This study examined the effect of LAGB on T2DM status in severely obese patients with T2DM. METHODS: This was a 2-year interim analysis of patients with T2DM who required daily hypoglycemic medication at baseline (N = 89) in the 5-year, open-label, prospective, observational LAP-BAND AP® EXperience (APEX) trial. Type 2 diabetes mellitus status was classified as "remission," "improved," "stable," or "worse" based on physician- and patient-reported changes in T2DM control and changes in hypoglycemic medication use. RESULTS: At baseline, 89 (22.5%) of 395 patients required daily hypoglycemic medication; 66 patients had data available after 2 years. Remission of T2DM occurred in 32 (48.5%) patients, improvement occurred in 31 (47.0%) patients, and no change occurred in 3 (4.5%) patients. Overall, 95.5% of patients experienced remission or improvement in T2DM status. Duration of T2DM in patients with remission or improvement after 2 years was 4.0 and 6.7 years, respectively (P = 0.082 between groups), and was associated with change in T2DM status (logistic regression, P = 0.069). Baseline BMI, change in BMI, and percent weight loss were not significantly different between the T2DM response groups. Percent excess weight loss was numerically, but not statistically significantly, greater in remitted (-56.1%) compared with the improved response (-42.9%) group (P = 0.134), and was correlated with change in T2DM status (logistic regression, P = 0.052). After 2 years, patients experienced remission or improvement of other obesity comorbidities. The rate of revisional surgery or explantation was 3.4%, and it was not significantly different between patients with and without T2DM (P = 0.687). CONCLUSION: Shorter duration of T2DM and greater percent excess weight loss were associated with an increased likelihood of remission or improvement in T2DM status through LAGB after 2 years. Laparoscopic adjustable gastric banding is a potential adjunctive treatment for obese patients with T2DM.

Effect of adjustable gastric banding on changes in gastroesophageal reflux disease (GERD) and quality of life.

OBJECTIVE: Bariatric surgery is an effective treatment for the reduction of weight in obese patients (BMI ≥ 40 kg/m(2) or 30 kg/m(2) with ≥1 comorbidities), who are refractory to behavioral and medical therapies. This study examined the effect of the adjustable gastric band (AGB) system on changes in gastroesophageal reflux disease (GERD) and patient-reported outcomes, including measures of quality of life. METHODS: Two-year interim analysis of patients (N = 171) in the 5 year, prospective APEX study who reported GERD prior to the AGB procedure. An unrecorded number of hiatal hernia repairs were conducted during the APEX study. RESULTS: At baseline, 171 of 395 patients (43%) reported GERD requiring daily medical therapy. After 2 years, 122 patients had sufficient data to assess outcome (71%). Complete resolution of GERD was reported in 98 patients (80%), improvement in 13 (11%), no change in 9 (7%), and worsening in 2 (2%). Overall, 91% of GERD patients experienced resolution and/or improvement of GERD. Baseline BMI was not significantly different among the GERD response categories (resolved, improved, and stable/worse), p = 0.4581. Mean ΔBMI and percentage excess weight loss (%EWL) were: -8.8 kg/m(2)/-0.9%, -11.4 kg/m(2)/-53.9%, -6.4 kg/m(2)/-36.1%, and -7.1 kg/m(2)/-31.2%, respectively. There were no significant differences in reductions in BMI or %EWL between responder groups (resolved versus stable/worse ΔBMI p = 0.1031, %EWL p = 0.0667 OR resolved/improved versus stable/worse ΔBMI p = 0.0918, %EWL p = 0.0552). After 2 years, resolution or improvement occurred in pre-existing comorbidities: type 2 diabetes (96%), hypertension (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), osteoarthritis (93%), and depression (75%). Patient satisfaction with AGB was assessed as: very satisfied/satisfied (87%), very satisfied (50%), dissatisfied (5.0%). Quality of life measured by the Obesity and Weight-Loss Quality of Life Instrument (GERD patients) significantly improved from baseline. CONCLUSION: Obese patients with GERD had meaningful improvement in patient-reported outcomes with the AGB system. In addition, other obesity-related comorbidities and measures of quality of life improved.

Interim results at 48 weeks of LAP-BAND AP experience (APEX) study: prospective, multicenter, open-label longitudinal patient observational study.

BACKGROUND: The development of laparoscopic adjustable gastric banding marked a breakthrough in minimally invasive bariatric surgery. The unique features of gastric banding, including device adjustability, lack of malabsorption, and easy reversibility, have contributed to its widespread use. Since Food and Drug Administration approval of the first laparoscopic adjustable gastric band, the device design has undergone engineering improvements. The LAP-BAND AP (LBAP) system received Food and Drug Administration approval in 2006. Little is known about the safety and efficacy of this new system. Our objective was to prospectively assess the efficacy and safety of the LBAP system in real-world clinical settings at 50 clinical centers throughout the United States. METHODS: In an open-label 5-year evaluation, 508 severely or morbidly obese patients from 50 centers in the United States underwent surgery using the LBAP system. The present interim report describes the results from 323 patients after ≥ 48 weeks of follow-up. RESULTS: By week 48, the patients had experienced a mean percentage of excess weight loss of 46% and a mean ± standard deviation reduction in the body mass index of 8.4 ± 3.69 kg/m(2). Sixteen patients (3.1%) experienced a severe device- or procedure-related adverse event. There were no deaths. CONCLUSION: These 48-week interim data demonstrate that the LBAP system offers a safe and effective therapy to reduce weight in severely obese patients.

Safety and effectiveness of bariatric surgery: Roux-en-y gastric bypass is superior to gastric banding in the management of morbidly obese patients: a response.

BACKGROUND: The recent article by Guller, Klein, Hagen was reviewed and discussed by the authors of this response to critically analyze the validity of the conclusions, at a time when patients and providers depend on peer reviewed data to guide their health care choices. The authors of this response all have high volume bariatric surgery practices encompassing experience with both gastric bypass and gastric banding, and have made significant contributions to the peer reviewed literature. We examined the assumptions of the paper, reviewed the main articles cited, provided more evidence from articles that were included in the materials and methods of the paper, but not cited, and challenge the conclusion that Roux-en-Y gastric bypass is superior to gastric banding. RESULTS AND DISCUSSION: The paper by Guller et al was subject to significant bias. The authors did not demonstrate an understanding of gastric banding, selectively included data with unfavorable results towards gastric banding, did not provide equal critique to the literature on gastric bypass, and deliberately excluded much of the favorable data on gastric banding. CONCLUSION: The paper's conclusion that gastric bypass is the procedure of choice is biased, unsubstantiated, not supported by the current literature and represents a disservice to the scientific and health care community.