Management strategies of anastomotic ulcer after gastric bypass and risk factors of recurrence.

BACKGROUND: Marginal ulcers (MU) after gastric bypass are a challenging problem. The first-line treatment is a medical therapy with eviction of risk factors but is sometimes insufficient. The management strategies of intractable ulcers are still not clearly defined. The aim of our study was to analyse the risk factors for recurrence, the management strategies used and their efficiencies. METHODS: Based on a retrospective analysis of all MU managed in our tertiary care centre of bariatric surgery during the last 14 years, a descriptive analysis of the cohort, the management strategies and their efficiency were analysed. A logistic regression was done to identify the independent associated risk factors of intractable ulcer. RESULTS: Fifty-six patients matched inclusion criteria: 30 were referred to us (13 Roux-en-Y Gastric Bypass-RYGB and 17 One Anastomosis Gastric Bypass-OAGB), 26 were operated on in our institution (24 RYGB and 2 OAGB). 11 patients had a complicated inaugural MU requiring an interventional procedure in emergency: 7 perforations, 4 haemorrhages. The majority of MU were treated medically as a first-line therapy (n = 45; 80.4%). 32 MU recurred: 20 patients required surgery as a 2nd line therapy, 6 were operated on as a 3rd line therapy and 1 had a surgery as a 5th line therapy. The OAGB was the only risk factor of recurrence (p = 0.018). We found that the Surgical management was significantly more frequent for patients with a OAGB (84% versus 35% for RYGB, p = 0.001); the most performed surgical procedure was a conversion of OAGB to RYGB (n = 11, 37.9%). CONCLUSION: Surgery was required for a large number of MU especially in case of recurrence, but recurrence can still occur after the surgery. The OAGB was the only risk factor of recurrence identified and conversion to RYGB seemed to be effective for the healing.

Digestive perforations related to endoscopy procedures: a local management charter based on local evidence and experts' opinion.

Background and study aims Perforations are a known adverse event of endoscopy procedures; a proposal for appropriate management should be available in each center as recommended by the European Society of Gastrointestinal Endoscopy. The objective of this study was to establish a charter for the management of endoscopic perforations, based on local evidence. Patients and methods Patients were included if they experienced partial or complete perforation during an endoscopic procedure between 2008 and 2018 (retrospectively until 2016, then prospectively). Perforations (size, location, closure) and management (imagery, antibiotics, surgery) were analyzed. Using these results, a panel of experts was asked to propose a consensual management charter. Results A total of 105 patients were included. Perforations occurred mainly during therapeutic procedures (91, 86.7%). Of the perforations, 78 (74.3 %) were diagnosed immediately and managed during the procedure; 69 of 78 (88.5 %) were successfully closed. Closures were more effective during therapeutic procedures (60 of 66, 90.9 %) than during diagnostic procedures (9 of 12, 75.0 %, P  = 0.06). Endoscopic closure was effective for 37 of 38 perforations (97.4 %) < 0.5 cm, and for 26 of 34 perforations (76.5 %) ≥ 0.5 cm ( P  < 0.05). For perforations < 0.5 cm, systematic computed tomography (CT) scan, antibiotics, or surgical evaluation did not improve the outcome. Four of 105 deaths (3.8 %) occurred after perforation, one of which was attributable to the perforation itself. Conclusions Detection and closure of perforations during endoscopic procedure had a better outcome compared to delayed perforations; perforations < 0.5 cm had a very good prognosis and CT scan, surgeon evaluation, or antibiotics are probably not necessary when the endoscopic closure is confidently performed. This work led to proposal of a local management charter.

Revision of Mason's procedure (vertical banded gastroplasty) to Roux-en-Y gastric bypass: role of an associated fundectomy in weight loss outcomes.

BACKGROUND: Vertical banded gastroplasty (VBG) presents a significant rate of long-term complications, and revisions are often necessary. Conversion to Roux-en-Y gastric bypass (RYGB) seems to be preferred, but literature data remain limited. OBJECTIVES: To analyze the indications, safety, results of conversions from VBG to RYGB, and to identify predictive factors of success or failure. SETTING: Two specialized centers of bariatric surgery. METHODS: This bicentric retrospective study included all the patients who benefited from a conversion from VBG to RYGB between 2008 and January 2020. Demographic characteristics, indications, preoperative workups, intraoperative data, complications, and weight loss results were analyzed. RESULTS: During the study period, 85 patients underwent a conversion to RYGB. The mean body mass index (BMI_ before conversion was 40.6 kg/m2. 82.3% of the patients were converted because of weight loss failure and 17.6% because of a complication of their VBG. The global rate of complications was 25%. After an average follow-up of 35 months and a rate of loss to follow-up of 33%, the mean BMI was 33.5 kg/m. The weight loss success rate according to Reinhold's criteria was 64.7%, and resolution of complications was obtained in 89.1%. The association of a fundectomy was a predictive factor of weight loss (odds ratio, .27; P = .04), whereas primary failure of the VBG was a predictive factor of failure. CONCLUSION: Conversion from VBG to RYGB remains the procedure of choice to achieve satisfying weight loss and resolution of functional complications. The addition of a fundectomy appeared to have a significant positive impact on weight loss outcomes.

Third bariatric procedure for insufficient weight loss or weight regain: how far should we go?

BACKGROUND: Revisional procedures in bariatric surgery are increasing with several debated failure risk factors, such as super obesity and old age. No study has yet evaluated the outcomes and risks of a third bariatric procedure indicated for weight loss failure or weight regain. OBJECTIVES: To assess failure risks of a third bariatric procedure according to Reinhold's criteria (percentage excess weight loss [%EWL] ≤50% and/or body mass index [BMI] ≥35 kg/m2). SETTING: A university-affiliated tertiary care center, France. METHODS: From 2009 to 2019, clinical data and weight loss results of patients who benefited from 3 bariatric procedures for weight loss failure or weight regain were collected prospectively and analyzed using a binary logistic regression. Weight loss failure was defined according to Reinhold's criteria. RESULTS: Among 1401 bariatric procedures performed, 336 patients benefited from 2 or more procedures, and 45 had a third surgery. Eleven patients that were reoperated on because of malnutrition or gastroesophageal reflux disease were excluded from the final analysis. Among 34 patients with 3 procedures because of weight loss failure or regain, mean BMI was 48.3 ± 8.3 kg/m2, and mean age was 30 ± 10.7 years. Three out of 34 patients (9%) presented a severe complication (Dindo-Clavien IIIb) and 2 (6%) had a minor one. Achieving Reinhold's weight loss criteria after the second bariatric procedure was a significant predictor of success of the third procedure (ß = 2.9 ± 1.3 S.E.). CONCLUSION: Not reaching Reinhold's criteria after a second bariatric procedure was identified as a significant risk factor of failure of a third procedure. A third surgery should be carefully discussed especially in case of primary failure of previous procedures.

Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol.

INTRODUCTION: Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE). METHODS AND ANALYSIS: The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50 kg/m2 will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group. ETHICS AND DISSEMINATION: The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT03610256.

Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial.

BACKGROUND: 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). METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: French Ministry of Health.

Laparoscopic Treatment of Gastro-Gastric Fistula After RYGB: Technical Points.

PURPOSE: Postoperative abdominal pain after Roux en Y gastric bypass associated with gastro esophageal reflux is difficult to manage. A gastro-gastric fistula can be the etiology and besides pain and weight regain, it can also be revealed by a dilatation of the excluded stomach and duodenum. METHODS: We present the case of a 45-year-old woman who had a medical history of revisional RYGB after failure of gastric band. She recently complained of recurrent epigastric abdominal pain and biliary GERD. Upper gastro intestinal endoscopy found biliary reflux gastritis. The CT scan with gas expansion and opacification revealed a dilated excluded stomach and duodenum leading to the diagnosis of gastro-gastric fistula. Because of pain and GERD correlated to this radiological finding, we decided to perform an exploratory laparoscopy. The patient was placed in a half-sitting position, surgeon between the legs. A 12-mmHg pneumoperitoneum was made. A 4-port technique was used. The first step consisted of a complete adhesiolysis. The second step consisted in the dissection of the excluded stomach, stuck to the gastric pouch, and revealed two gastro-gastric fistulas treated by stapling. An epiploplasty was performed on the excluded stomach and the staple line of the gastric pouch was invaginated. RESULTS: Postoperative course was uneventful. One year later, she had no more reflux and no more pain. CONCLUSION: Causes of abdominal pain and GERD after RYGB are difficult to identify. Gastro-gastric fistula is one of them and should be evoked when biliary reflux and abdominal pain appear.

Need for Intensive Nutrition Care After Bariatric Surgery.

Severe nutrition complications after bariatric surgery remain poorly described. The aim of this case series was to identify specific factors associated with nutrition complications after bariatric surgery and to characterize their nutrition disorders. We retrospectively reviewed all people referred to the clinical nutrition intensive care unit of our university hospital after bariatric surgery from January 2013 to June 2015. Twelve persons who required artificial nutrition supplies (ie, enteral nutrition or parenteral nutrition) were identified. Seven persons underwent a "one-anastomosis gastric bypass" (OAGB) or "mini gastric bypass," 2 underwent a Roux-en-Y gastric bypass, 2 had a sleeve gastrectomy, and 1 had an adjustable gastric band. This case series suggests that OAGB could overexpose subjects to severe nutrition complications requiring intensive nutrition care and therefore cannot be considered a "mini" bariatric surgery. Even if OAGB is often considered a simplified surgical technique, it obviously requires as the other standard bariatric procedures a close follow-up by experimented teams aware of its specific complications.

Dilatation of Sleeve Gastrectomy: Myth or Reality?

OBJECTIVES: The success of longitudinal sleeve gastrectomy (LSG) is perceived as being potentially limited by dilatation of the remaining gastric tube during the follow-up. The aim of this prospective study was to determine the incidence and the characteristics of sleeve dilatation during the first post-operative year. MATERIALS AND METHODS: Gastric volumetry using 3D gastric computed tomography with gas expansion was performed in 54 successive subjects who underwent an LSG for morbid obesity at 3 and 12 months following surgery. Total gastric volume, volume of the gastric tube and the antrum, and diameter of the gastric tube were assessed after multiplanar reconstructions. An increase of at least 25 % of the total gastric volume was considered as sleeve dilatation. Percentage of excess BMI loss (%EBMIL) and daily caloric intakes were recorded during the first 18 months. RESULTS: Sixty-one percent of the subjects experienced sleeve dilatation 1 year after surgery. The gastric tube was mainly involved in the sleeve dilatation process (+91 %). Sleeve dilatation occurred especially in subjects with smaller total gastric volume at baseline (189 vs 236 ml, p = 0.02). Daily caloric intake was similar between the groups at each point of the follow-up. No difference concerning %EBMIL was observed between the groups during the 18 months of follow-up. CONCLUSIONS: Sleeve dilatation occurred in more than 50 % of the patients. Dilatation was not necessarily linked to an increase of daily caloric intake and insufficient weight loss during the first 18 months following surgery. Small LSG at baseline is at higher risk of dilatation.

Transition from physical activity to inactivity increases skeletal muscle miR-148b content and triggers insulin resistance.

This study investigated miR-148b as a potential physiological actor of physical inactivity-induced effects in skeletal muscle. By using animal and human protocols, we demonstrated that the early phase of transition toward inactivity was associated with an increase in muscle miR-148b content, which triggered the downregulation of NRAS and ROCK1 target genes. Using human myotubes, we demonstrated that overexpression of miR-148b decreased NRAS and ROCK1 protein levels, and PKB phosphorylation and glucose uptake in response to insulin. Increase in muscle miR-148b content might thus participate in the decrease in insulin sensitivity at the whole body level during the transition toward physical inactivity.

Impact of sleeve gastrectomy volumes on weight loss results: a prospective study.

BACKGROUND: Causes of weight loss failure after sleeve gastrectomy (SG) are still controversial. The impact of the size of the sleeve continues to be debated. OBJECTIVE: The aim of our study was to determine the impact of sleeve volumes assessed at 3 months using gastric computed tomography (CT) on weight loss at 18 months. SETTING: University Hospital, France. METHODS: Sixty-seven obese patients eligible for SG were prospectively evaluated. Sleeve volumes were assessed postsurgery using 3-dimensional gastric CT with gas at 3 months and weight loss outcomes recorded up to 18 months. The population was divided into 2 groups: the first tertile (n = 22) with the smallest gastric volume was defined as the "small sleeve" group (SSG) and the rest of the population (n = 45) was defined as the "without small sleeve" group (WSSG). RESULTS: No patients were lost to follow-up. In the SSG, overall gastric volume was 133±7 mL versus 264±11 mL for the WSSG (P<.0001). Percentage excess body mass index loss (%EBMIL) during the first postoperative 18 months was significantly greater in the SSG compared with the WSSG (P = .04). Although the volume of the gastric tube was not correlated with weight loss (r =-.04, P = .78), there was a negative linear correlation between the volume of the antrum and the %EBMIL at 18 months (r =-.39, P = .005). A narrow gastric tube was also associated with a high digestive intolerance and reflux. CONCLUSION: Our data suggest that performing the sleeve with a not-too-small bougie size and a radical antrectomy could improve weight loss and digestive tolerance.

High-resolution Impedance Manometry after Sleeve Gastrectomy: Increased Intragastric Pressure and Reflux are Frequent Events.

INTRODUCTION AND PURPOSE: Sleeve gastrectomy (SG) is gaining ground in the field of bariatric surgery. Data are scarce on its impact on esophagogastric physiology. Our aim was to evaluate the impact of SG on esophagogastric motility with high-resolution impedance manometry (HRIM) and to assess the usefulness of HRIM in patients with upper gastrointestinal (GI) symptoms after SG. METHODS: A retrospective analysis of 53 cases of HRIM performed after SG was conducted. Upper GI symptoms at the time of HRIM were scored. HRIM was analyzed according to the Chicago classification v3.0. A special attention was devoted to the occurrence of increased intragastric pressure (IIGP) after water swallows and reflux episodes as detected with impedance. A measurement of sleeve volume and diameter was performed with CT scan in a subgroup of patients. RESULTS: IIGP occurred very frequently in patients after SG (77 %) and was not associated with any upper GI symptoms, specific esophageal manometric profile, or impedance reflux. Impedance reflux episodes were also frequently observed after SG (52 %): they were significantly associated with gastroesophageal reflux (GER) symptoms and ineffective esophageal motility. The sleeve volume and diameters were also significantly smaller in patients with impedance reflux episodes (p < 0.01). CONCLUSION: SG significantly modified esophagogastric motility. IIGP is frequent, not correlated to symptoms, and should be regarded as a HRIM marker of SG. Impedance reflux episodes were also frequent, associated with GER symptoms and esophageal dysmotility. HRIM may thus have a clinical impact on the management of patients with upper GI symptoms after SG.

Should we wait for metabolic complications before operating on obese patients? Gastric bypass outcomes in metabolically healthy obese individuals.

BACKGROUND: A subgroup of obese patients without metabolic disorders has been identified and defined as metabolically healthy but morbidly obese (MHMO). OBJECTIVES: To compare Roux-en-Y gastric bypass (RYGB) outcomes between MHMO and metabolically unhealthy morbidly obese (MUMO) patients to assess whether the obesity phenotype could affect the results. SETTING: A university-affiliated tertiary care center. METHODS: One hundred nineteen consecutive patients underwent RYGB; 102 completed the 2-year follow-up and were divided into 2 groups (MHMO and MUMO) according to Wildman criteria, including blood pressure, triglycerides, high-density lipoprotein cholesterol (HDL-C), fasting blood sugar, C-reactive protein (CRP), and homeostasis model assessment of insulin resistance (HOMA-IR). Weight loss and metabolic parameter changes were analyzed. RESULTS: Twenty-one of 102 (20.6%) patients were identified as MHMO; they were mostly women (90.5%) and were significantly younger than MUMO patients (39.4 ± 9.1 yr versus 47.2 ± 10, P = .001); 12.6% were lost to follow-up. MHMO phenotype was significantly associated with a greater percentage of excess body mass index loss (P = .03), independent of gender, age, and redo procedures. All metabolic parameters were significantly improved 2 years after surgery in the MUMO group. HOMA-IR, CRP, and triglycerides were significantly lower 2 years after surgery in the MHMO group, whereas fasting blood sugar and HDL-C were unchanged. At 2 years of follow-up, 92.3% of the population was metabolically healthy. CONCLUSIONS: RYGB is an effective procedure to achieve weight loss and had a strong positive metabolic effect in both MHMO and MUMO phenotypes. RYGB led to an increase of the metabolically healthy status and may prevent or delay the onset of metabolic disorders.

Preoperative fat-free mass: a predictive factor of weight loss after gastric bypass.

Weight loss failure occurs in 8% to 40% of patients after gastric bypass (GBP). The aim of our study was to analyse the predictive factors of weight loss at 1 year so as to select the best candidates for this surgery and reduce the failures. We included 73 patients treated by laparoscopic GBP. We retrospectively analysed the predictive factors of weight loss in kilograms as well as excess weight loss in percentage (EWL%) at 1 year. The population was divided into tertiles so as to compare the sub-group with the highest weight loss with the sub-group with the least satisfactory results. The significantly predictive factors of a better weight loss in kilograms were male, higher initial weight (144 versus 118 kg, p = 0.002), a significant early weight loss and a higher preoperative percentage of fat-free mass (FFM%; p = 0.03). A higher FFM% was also associated with a better EWL% (p = 0.004). The preoperative FFM (in kilograms) was the principal factor accounting for the weight loss at 1 year regardless of age, gender, height and initial body mass index (BMI; p < 0.0001). There was a better correlation between FFM and weight loss (Spearman test, p = 0.0001) than between initial BMI and weight loss (p = 0.016). We estimated weight loss at 1 year according to initial FFM using the formula: 0.5 kg of lost weight per kilogram of initial FFM. The initial FFM appears to be a decisive factor in the success of GBP. Thus, the sarcopoenic patients would appear to be less suitable candidates for this surgery.