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One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB). This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, or arthritis), and were aged 18–65 years. Key exclusion criteria were a history of oesophagitis, Barrett's oesophagus, severe gastro-oesophageal reflux disease resistant to proton-pump inhibitors, and previous bariatric surgery. Participants were randomly assigned (1:1) to OAGB or RYGB, stratified by centre with blocks of variable size; the study was open-label, with no masking required. RYGB consisted of a 150 cm alimentary limb and a 50 cm biliary limb and OAGB of a single gastrojejunal anastomosis with a 200 cm biliopancreatic limb. The primary endpoint was percentage excess BMI loss at 2 years. The primary endpoint was assessed in the per-protocol population and safety was assessed in all randomised participants. This study is registered with ClinicalTrials.gov, number NCT02139813, and is now completed. From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m2 (SD 5·6), 176 (75%) of 234 participants were female, and 58 (27%) of 211 with available data had type 2 diabetes. After 2 years, mean percentage excess BMI loss was −87·9% (SD 23·6) in the OAGB group and −85·8% (SD 23·1) in the RYGB group, confirming non-inferiority of OAGB (mean difference −3·3%, 95% CI −9·1 to 2·6). 66 serious adverse events associated with surgery were reported (24 in the RYGB group vs 42 in the OAGB group; p=0·042), of which nine (21·4%) in the OAGB group were nutritional complications versus none in the RYGB group (p=0·0034). OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect. French Ministry of Health.

Observational studies suggest that bariatric–metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial. We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25–70 years with obesity (BMI 30–55 kg/m2), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov, NCT03524365. Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19–5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23–6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management. Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH. Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy.

Background A short-term randomized controlled trial shows that the one anastomosis gastric bypass (OAGB) is a safe and effective alternative to the Roux-en-Y gastric bypass (RYGB). Objective The aim of this study is to evaluate the OAGB at our University Hospital between 2006 and 2013. Patients One thousand patients have undergone an OAGB. Data were collected on all consecutive patients. The mean follow-up period was 31 months (SD, 26.3; range, 12–82.9), and complete follow-up was available in 126 of 175 patients (72 %) at 5 years after surgery. Results Mortality rate was 0.2 %. Overall morbidity was 5.5 %; 34 required reoperations: i.e., 6 leaks, 5 obstructions, 5 incisional hernias, 7 biliary refluxes, 2 perforated ulcers, 2 bleeds, 2 abscesses, and 1 anastomotic stricture. Four patients were reoperated for weight regain. Overall rate of marginal ulcers was 2 % ( n  = 20), all in heavy smokers. Conversion from an OAGB to a RYGB was required in nine cases (0.9 %): seven for intractable biliary reflux, two for a marginal ulcer. At 5 years, percent excess body mass index loss was 71.6 ± 27 %. One hundred patients with type-2 diabetes, with a mean preoperative HbA1C of 7.7 ± 1.9 %, were followed for >2 years; the total resolution rate was 85.7 %. Conclusion This study confirms that the OAGB is an effective procedure for morbid obesity with comparable outcomes to RYGB; in addition, it seems to be safer with lower morbidity. Its technical simplicity represents a real advantage and makes it an option that should be considered by all bariatric surgeons.

IntroductionData on postoperative bile reflux after one anastomosis gastric bypass (OAGB) is lacking. Bile reflux scintigraphy (BRS) has been shown to be a reliable non-invasive tool to assess bile reflux after OAGB. We set out to study bile reflux after OAGB with BRS and endoscopy in a prospective series (RYSA Trial).MethodsForty patients (29 women) underwent OAGB between November 2016 and December 2018. Symptoms were reported and upper gastrointestinal endoscopy (UGE) was done preoperatively. Six months after OAGB, bile reflux was assessed in UGE findings and as tracer activity found in gastric tube and esophagus in BRS (follow-up rate 95%).ResultsTwenty-six patients (68.4%) had no bile reflux in BRS. Twelve patients (31.6%) had bile reflux in the gastric pouch in BRS and one of them (2.6%) had bile reflux also in the esophagus 6 months postoperatively. Mean bile reflux activity in the gastric pouch was 5.2% (1–21%) of total activity. De novo findings suggestive of bile reflux (esophagitis, stomal ulcer, foveolar inflammation of gastric pouch) were found for 15 patients (39.5%) in postoperative UGE. BRS and UGE findings were significantly associated (P = 0.022). Eight patients experienced de novo reflux symptoms at 6 months, that were significantly associated with BRS and de novo UGE findings postoperatively (P = 0.033 and 0.0005, respectively).ConclusionPostoperative bile reflux in the gastric pouch after OAGB is a common finding in scintigraphy and endoscopy. The long-term effects of bile exposure will be analyzed in future reports after a longer follow-up.Trial registrationClinical Trials Identifier NCT02882685

BackgroundRecent reports have demonstrated that de novo reflux and worsening of pre-existing symptoms occur after SG; concerns are still expressed about the risk of symptomatic biliary reflux gastritis and oesophagitis. The aim of our study was to investigate and compare the rate of postoperative acid and non-acid reflux following Mini-/One anastomosis gastric bypass (MGB/OAGB) and laparoscopic sleeve gastrectomy (LSG).Study designA prospective randomized open-label, controlled trial registered on clinicaltrial.gov (NCT number: NCT02987673) has been carried out to evaluate esophagogastric junction exposure to reflux in the first year after MGB/OAGB and LSG using high impedance manometry, endoscopy, and a validated questionnaire.ResultsA total of 58 individuals were eventually enrolled in this trial and represented the per-protocol population (n = 28 MGB/OAGB, n = 30 LSG). No difference was found between the two groups in terms of demographic characteristics, PAGI-SYM score, acid exposure time percent of the esophagus (AET%), esophagitis, and other HRiM and MII-pH data at baseline. Comparing MII-pH outcomes of the two groups, AET% resulted significantly higher after LSG at 12 months. Endoscopic findings showed a significant increase of esophagitis ≥ B in the LSG group after 1 year; postoperative esophagitis ≥ B resulted also significantly worsened after LSG when compared to MGB/OAGB.ConclusionSince AET% and rate of esophagitis are significantly higher after LSG when compared to MGB/OAGB, this procedure should be preferred in case of preoperative subclinical reflux or low grade (A) esophagitis.

PurposeGastroesophageal reflux disease (GERD) is an issue after one anastomosis gastric bypass (OAGB) and modification of OAGB with adding an anti-reflux system may decrease the incidence of postoperative GERD. This study aimed to compare the efficacy of the anti-reflux mechanism to treat preoperative GERD and prevent de novo GERD.MethodsA prospective randomized clinical trial study was conducted on patients with a body mass index of 40 and more from August 2020 to February 2022. Patients undergoing one anastomosis gastric bypass with and without anti-reflux sutures (groups A and B, respectively). These patients had follow-ups for one year after the surgery. GERD symptoms were assessed in all the patients using the GERD symptom questionnaire.ResultsThe mean age was 39.5 ± 9.8 years and 40.7 ± 10.2 years in groups A and B respectively. GERD symptoms remission occurred in 76.5% and 68.4% of patients in groups A and B, respectively. The incidence of de novo GERD symptoms was lower in group A, compared to group B (6.2% and 16.1% in groups A and B respectively), without any statistically significant difference (p-value: 0.239).ConclusionGERD symptoms and de novo GERD after OAGB seems to be under-reported after OAGB. This study suggests that applying an anti-reflux suture can decrease de novo GERD symptoms.

Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate. This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were offered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01137201. Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n=1259) or non-closure (n=1248). 2503 (99·8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99·0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was significantly reduced in the closure group (cumulative probability 0·055 for closure vs 0·102 for non-closure, hazard ratio 0·56, 95% CI 0·41–0·76, p=0·0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4·3%] for closure vs 35 [2·8%] for non-closure, odds ratio 1·55, 95% CI 1·01–2·39, p=0·044), mainly because of kinking of the jejunojejunostomy. The results of our study support the routine closure of the mesenteric defects in laparoscopic gastric bypass surgery. However, closure of the mesenteric defects might be associated with increased risk of early small bowel obstruction caused by kinking of the jejunojejunostomy. Örebro County Council, Stockholm City Council, and the Erling-Persson Family Foundation.

Abstract Context We compared the incidence of hypoglycemia after Roux-en-Y gastric bypass (RYGB) vs sleeve gastrectomy (SG). Design, Setting, and Main Outcome Measures Randomized, open-label trial conducted at the outpatient obesity clinic in a university hospital in Rome, Italy. The primary aim was the incidence of reactive hypoglycemia (<3.1 mmol/L after 75-g oral glucose load) at 1 year after surgery. Secondary aims were hypoglycemia under everyday life conditions, insulin sensitivity, insulin secretion, and lipid profile. Results Of 175 eligible patients, 120 were randomized 1:1 to RYGB or SG; 117 (93%) completed the 12-month follow-up. Reactive hypoglycemia was detected in 14% and 29% of SG and RYGB patients (P = 0.079), respectively, with the effect of treatment in multivariate analysis significant at P = 0.018. Daily hypoglycemic episodes during continuous glucose monitoring did not differ between groups (P = 0.75). Four of 59 RYGB subjects (6.8%) had 1 to 3 hospitalizations for symptomatic hypoglycemia vs 0 in SG. The static β-cell glucose sensitivity index increased after both treatments (P < 0.001), but the dynamic β-cell glucose sensitivity index increased significantly in SG (P = 0.008) and decreased in RYGB (P = 0.004 for time × treatment interaction). Whole-body insulin sensitivity increased about 10-fold in both groups. Conclusions We show that reactive hypoglycemia is no less common after SG and is not a safer option than RYGB, but RYGB is associated with more severe hypoglycemic episodes. This is likely due to the lack of improvement of β-cell sensitivity to changes in circulating glucose after RYGB, which determines an inappropriately high insulin secretion. We found that reactive hypoglycemia is no less common after SG than after RYGB, but RYGB is associated with more severe hypoglycemic episodes.

Background No randomized comparative trials have presented long-term outcomes for laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study was designed to compare the efficacy and safety of these two procedures. Methods From January 2007 to July 2008, 64 eligible patients were randomly assigned to LSG or LRYGB. During the 5-year follow-up, we compared morbidity rate, body mass index (BMI), percent of excess weight loss (%EWL), Moorehead-Ardelt (M-A) II quality of life, and resolution or improvement rate of obesity-related comorbidities between the groups. Results Both groups were matched with respect to age, gender, and BMI. Slightly more major complications were observed in patients undergoing LRYGB ( P  > 0.05). Weight loss was significantly better with LRYGB except during the first postoperative year. At 5 years, %EWL for LSG and LRYGB was 63.2 ± 24.5 % and 76.2 ± 21.7 % ( P  = 0.02), respectively. No statistical difference was observed in quality of life between the groups at all intervals ( P  > 0.05). At the last follow-up, most comorbidities in both groups were resolved or improved, with no difference between the groups ( P  > 0.05). Conclusion LRYGB and LSG are equally safe and effective in quality of life and improvement or resolution of comorbidities, and LRYGB possesses the superiority in terms of weight loss. Further studies are needed to evaluate micronutrient deficiencies of these procedures.

BackgroundFailure occurs in up to 60% of the patients that were treated with primary restrictive bariatric operations such as Laparoscopic Adjustable Gastric Banding (LAGB), or restrictive/metabolic operations like Laparoscopic Sleeve Gastrectomy (LSG). Insufficient weight loss and weight regain are the most commonly reported reasons of failure. The aim of this retrospective multicenter study was to compare One Anastomosis Gastric Bypass (OAGB) to Roux-en-Y Gastric Bypass (RYGB) as a revisional procedure in terms of weight loss, procedure time, complication rate and morbidity.Methods491 patients operated on between 2012 and 2017 for failed restrictive surgery were included in this study (OAGB (n=185) or RYGB (n=306)). Failure was defined as total weight loss (TWL) less than 25%, excess weight loss (EWL) less than 50% and/or a remaining body mass index (BMI) larger than 40 kg/m2 at two years of follow up. Primary outcome measures were %TWL and % excess BMI loss (EBMIL) at 12, 24 and 36 months of follow-up. Secondary outcomes were procedure time, reduction of comorbidity, early and late complication rate, and mortality.Results%TWL was significantly larger in the OAGB group at 12 months (mean 24.1±9.8 vs. 21.9±9.7, p = 0.023) and 24 months (mean 23.9±11.7 vs. 20.5±11.2, p = 0.023) of follow-up. %EBMIL was significantly larger in the OAGB group at 12 months (mean 69.0±44.6 vs. 60.0±30.1, p = 0.014) and 24 months (mean 68.6±51.6 vs. 56.4±35.4, p = 0.025) of follow-up. Intra-abdominal complications (leakage, bleeding, intra-abdominal abscess and perforation) occurred less frequently after revisional OAGB (1.1% vs. 4.9%, p = 0.025). Surgical intervention for biliary reflux (5.4% vs. 0.3%, p < 0.001) was more prevalent in the OAGB group. Surgical intervention for internal herniation (0.0% vs. 4.9%, p = 0.002) was more prevalent in the RYGB group.ConclusionsThis study suggests that OAGB is superior to RYGB as a remedy for insufficient weight loss and weight regain after failed restrictive surgery with more weight loss and a lower early complication rate. To substantiate these findings, further research from prospective randomized controlled trials is needed.