Risk-Benefit Balance of Simultaneous Gastric Bypass or Sleeve Gastrectomy and Concomitant Cholecystectomy: A Comprehensive Nationwide Cohort of 289,627 Patients.

OBJECTIVE: To assess the relevance of concomitant laparoscopic metabolic bariatric surgery (MBS) and cholecystectomy. BACKGROUND: Because of the massive weight loss it induces, MBS is associated with an increase in the frequency of gallstones. However, no consensus yet exists on the risk-to-benefit ratio of a concomitant cholecystectomy (CC) during MBS to prevent long-term biliary complications. METHODS: This nationwide retrospective cohort research was conducted in 2 parts using information from a national administrative database (PMSI). The 90-day morbidity of MBS with or without CC was first compared in a matched trial (propensity score). Second, we observed medium-term biliary complication following MBS when no CC had been performed during MBS up to 9 years after MBS (minimum 18 months). RESULTS: Between 2013 and 2020, 289,627 patients had a sleeve gastrectomy (SG: 70%) or a gastric bypass (GBP: 30%). The principal indications of CC were symptomatic cholelithiasis (79.5%) or acute cholecystitis (3.6%). Prophylactic CC occurred only in 15.5% of the cases. In our matched-group analysis, we included 9323 patients in each arm. The complication rate at day 90 after surgery was greater in the CC arm [odds ratio=1.3 (1.2-1.5), P <0.001], independently of the reason of the CC. At 18 months, there was a 0.1% risk of symptomatic gallstone migration and a 0.08% risk of biliary pancreatitis. At 9 years, 20.5±0.52% of patients underwent an interval cholecystectomy. The likelihood of interval cholecystectomy decreased from 5.4% per year to 1.7% per year after the first 18 months the whole cohort, risk at 18 months of symptomatic gallstone migration was 0.1%, of pancreatitis 0.08%, and of angiocholitis 0.1%. CONCLUSION: CC during SG and GBP should be avoided. In the case of asymptomatic gallstones after MBS, prophylactic cholecystectomy should not be recommended.

Impact of Robotic Assistance on Complications in Bariatric Surgery at Expert Laparoscopic Surgery Centers: A Retrospective Comparative Study With Propensity Score.

OBJECTIVE: To investigate the way robotic assistance affected rate of complications in bariatric surgery at expert robotic and laparoscopic surgery facilities. BACKGROUND: While the benefits of robotic assistance were established at the beginning of surgical training, there is limited data on the robot's influence on experienced bariatric laparoscopic surgeons. METHODS: We conducted a retrospective study using the BRO clinical database (2008-2022) collecting data of patients operated on in expert centers. We compared the serious complication rate (defined as a Clavien score≥3) in patients undergoing metabolic bariatric surgery with or without robotic assistance. We used a directed acyclic graph to identify the variables adjustment set used in a multivariable linear regression, and a propensity score matching to calculate the average treatment effect (ATE) of robotic assistance. RESULTS: The study included 35,043 patients [24,428 sleeve gastrectomy (SG); 10,452 Roux-en-Y gastric bypass (RYGB); 163 single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S)], with 938 operated on with robotic assistance (801 SG; 134 RYGB; 3 SADI-S), among 142 centers. Overall, we found no benefit of robotic assistance regarding the risk of complications (average treatment effect=-0.05, P =0.794), with no difference in the RYGB+SADI group ( P =0.322) but a negative trend in the SG group (more complications, P =0.060). Length of hospital stay was decreased in the robot group (3.7±11.1 vs 4.0±9.0 days, P <0.001). CONCLUSIONS: Robotic assistance reduced the length of stay but did not statistically significantly reduce postoperative complications (Clavien score≥3) following either GBP or SG. A tendency toward an elevated risk of complications following SG requires more supporting studies.

Career Needs Assessment for Early Career Academic Surgeons Using a Modified Accelerated Delphi Process.

INTRODUCTION: Over the past 2 decades, physicians' wellbeing has become a topic of interest. It is currently unclear what the current needs are of early career academic surgeons (ECAS). METHODS: Consensus statements on academic needs were developed during a Delphi process, including all presenters from the previous European Surgical Association (ESA) meetings (2018-2022). The Delphi involved (1) a literature review, (2) Delphi form generation, and (3) an accelerated Delphi process. The Delphi form was generated by a steering group that discussed findings identified within the literature. The modified accelerated e-consensus approach included 3 rounds over a 4-week period. Consensus was defined as >80% agreement in any round. RESULTS: Forty respondents completed all 3 rounds of the Delphi. Median age was 37 years (interquartile range 5), and 53% were female. Majority were consultant/attending (52.5%), followed by PhD (22.5%), fellowship (15%), and residency (10%). ECAS was defined as a surgeon in 'development' years of clinical and academic practice relative to their career goals (87.9% agreement). Access to split academic and clinical contracts is desirable (87.5%). Consensus on the factors contributing to ECAS underperformance included: burnout (94.6%), lack of funding (80%), lack of mentorship (80%), and excessive clinical commitments (80%). Desirable factors to support ECAS development included: access to e-learning (90.9%), face-to-face networking opportunities (95%), support for research team development (100%), and specific formal mentorship (93.9%). CONCLUSION: The evolving role and responsibilities of ECAS require increasing strategic support, mentorship, and guidance on structured career planning. This will facilitate workforce sustainability in academic surgery in the future.

Surgery for Primary Aldosteronism in France From 2010 to 2020 - Results from the French-Speaking Association of Endocrine Surgery (AFCE): Eurocrine Study Group.

OBJECTIVE: Describe the diagnostic workup and postoperative results for patients treated by adrenalectomy for primary aldosteronism in France from 2010 to 2020. BACKGROUND: Primary aldosteronism (PA) is the underlying cause of hypertension in 6% to 18% of patients. French and international guidelines recommend CT-scan and adrenal vein sampling as part of diagnostic workup to distinguish unilateral PA amenable to surgical treatment from bilateral PA that will require lifelong antialdosterone treatment.Adrenalectomy for unilateral primary aldosteronism has been associated with complete resolution of hypertension (no antihypertensive drugs and normal ambulatory blood pressure) in about one-third of patients and complete biological success in 94% of patients.These results are mainly based on retrospective studies with short follow-up and aggregated patients from various international high-volume centers. METHODS: Here we report results from the French-Speaking Association of Endocrine Surgery (AFCE) using the Eurocrine® Database. RESULTS: Over 11 years, 385 patients from 10 medical centers were eligible for analysis, accounting for >40% of adrenalectomies performed in France for primary aldosteronism over the period.Preoperative workup was consistent with guidelines for 40% of patients. Complete clinical success (CCS) at the last follow-up was achieved in 32% of patients, and complete biological success was not sufficiently assessed.For patients with 2 follow-up visits, clinical results were not persistent at 1 year for one-fifth of patients.Factors associated with CCS on multivariate analysis were body mass index, duration of hypertension, and number of antihypertensive drugs. CONCLUSIONS: These results call for an improvement in thorough preoperative workup and long-term follow-up of patients (clinical and biological) to early manage hypertension and/or PA relapse.

Primary Graft Function and 5 Year Insulin Independence After Pancreas and Islet Transplantation for Type 1 Diabetes: A Retrospective Parallel Cohort Study.

In islet transplantation (ITx), primary graft function (PGF) or beta cell function measured early after last infusion is closely associated with long term clinical outcomes. We investigated the association between PGF and 5 year insulin independence rate in ITx and pancreas transplantation (PTx) recipients. This retrospective multicenter study included type 1 diabetes patients who underwent ITx in Lille and PTx in Nantes from 2000 to 2022. PGF was assessed using the validated Beta2-score and compared to normoglycemic control subjects. Subsequently, the 5 year insulin independence rates, as predicted by a validated PGF-based model, were compared to the actual rates observed in ITx and PTx patients. The study enrolled 39 ITx (23 ITA, 16 IAK), 209 PTx recipients (23 PTA, 14 PAK, 172 SPK), and 56 normoglycemic controls. Mean[SD] PGF was lower after ITx (ITA 22.3[5.2], IAK 24.8[6.4], than after PTx (PTA 38.9[15.3], PAK 36.8[9.0], SPK 38.7[10.5]), and lower than mean beta-cell function measured in normoglycemic control: 36.6[4.3]. The insulin independence rates observed at 5 years after PTA and PAK aligned with PGF predictions, and was higher after SPK. Our results indicate a similar relation between PGF and 5 year insulin independence in ITx and solitary PTx, shedding new light on long-term transplantation outcomes.

Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study.

BACKGROUND & AIMS: Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting. METHODS: Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries. RESULTS: Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p < .001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p < .001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p < .001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year). CONCLUSIONS: Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting. CLINICALTRIALS: gov Identifier: NCT00903799.

Bariatric Surgery and Osteoporosis.

It has been increasingly acknowledged that bariatric surgery adversely affects skeletal health. After bariatric surgery, the extent of high-turnover bone loss is much greater than what would be expected in the absence of a severe skeletal insult. Patients also experience a significant deterioration in bone microarchitecture and strength. There is now a growing body of evidence that suggests an association between bariatric surgery and higher fracture risk. Although the mechanisms underlying the high-turnover bone loss and increase in fracture risk after bariatric surgery are not fully understood, many factors seem to be involved. The usual suspects are nutritional factors and mechanical unloading, and the roles of gut hormones, adipokines, and bone marrow adiposity should be investigated further. Roux-en-Y gastric bypass (RYGB) was once the most commonly performed bariatric procedure worldwide, but sleeve gastrectomy (SG) has now become the predominant bariatric procedure. Accumulating evidence suggests that RYGB is associated with a greater reduction in BMD, a greater increase in markers of bone turnover, and a higher risk of fracture than SG. These findings should be taken into consideration in determining the most appropriate bariatric procedure for patients, especially those at higher fracture risk. Before and after all bariatric procedures, sufficient calcium, vitamin D and protein intake, and adequate physical activity, are needed to counteract negative impacts on bone. There are no studies to date that have evaluated the effect of osteoporosis treatment on high-turnover bone loss after bariatric surgery. However, in patients with a diagnosis of osteoporosis, anti-resorptive agents may be considered.

Delayed gastric emptying following distal pancreatectomy: incidence and predisposing factors.

BACKGROUND: Delayed gastric emptying (DGE) following elective distal pancreatectomy (DP) is poorly known. This study aimed to report incidence of DGE following DP, to identify its predisposing factors, and to assess its impact on hospital stay. METHODS: Patients who had elective DP without additional organ or vascular resection (2012-2017) in two academic hospitals were included. Factors predisposing to DGE, defined according to the International Study Group of Pancreatic Surgery, were identified by multivariate analysis. A systematic review was performed to evaluate DGE incidence following elective DP. RESULTS: 311 elective DPs were performed. Three perioperative mortalities (1.0%) were unrelated to DGE. DGE occurred in 31 (10.0%) patients (grade A = 21, grade B = 7, grade C = 3) with a median hospital stay of 16 (13-22) days versus 10 (7-14) without DGE (p < 0.001). In multivariate analysis, predisposing factors of DGE were age>75 years (OR = 4.32 [1.53-12.19]; p = 0.006), open approach (OR = 2.97 [1.1-8]; p = 0.031) and POPF grade B-C (OR = 2.54 [1.05-6.1]; p = 0.038). The systematic review identified 7 series including 876 patients with an overall 8.1% DGE incidence. CONCLUSION: DGE complicates around 10% of elective DP. Laparoscopic approach and prevention of POPF should be encouraged to reduce DGE incidence.

Characterization of one anastomosis gastric bypass and impact of biliary and common limbs on bile acid and postprandial glucose metabolism in a minipig model.

The alimentary limb has been proposed to be a key driver of the weight-loss-independent metabolic improvements that occur upon bariatric surgery. However, the one anastomosis gastric bypass (OAGB) procedure, consisting of one long biliary limb and a short common limb, induces similar beneficial metabolic effects compared to Roux-en-Y Gastric Bypass (RYGB) in humans, despite the lack of an alimentary limb. The aim of this study was to assess the role of the length of biliary and common limbs in the weight loss and metabolic effects that occur upon OAGB. OAGB and sham surgery, with or without modifications of the length of either the biliary limb or the common limb, were performed in Gottingen minipigs. Weight loss, metabolic changes, and the effects on plasma and intestinal bile acids (BAs) were assessed 15 days after surgery. OAGB significantly decreased body weight, improved glucose homeostasis, increased postprandial GLP-1 and fasting plasma BAs, and qualitatively changed the intestinal BA species composition. Resection of the biliary limb prevented the body weight loss effects of OAGB and attenuated the postprandial GLP-1 increase. Improvements in glucose homeostasis along with changes in plasma and intestinal BAs occurred after OAGB regardless of the biliary limb length. Resection of only the common limb reproduced the glucose homeostasis effects and the changes in intestinal BAs. Our results suggest that the changes in glucose metabolism and BAs after OAGB are mainly mediated by the length of the common limb, whereas the length of the biliary limb contributes to body weight loss.NEW & NOTEWORTHY Common limb mediates postprandial glucose metabolism change after gastric bypass whereas biliary limb contributes to weight loss.

Partial Versus Total Thyroidectomy: What Influences Most Surgeons' Decision? Analysis of a Nationwide Cohort of 375,810 Patients Over 10 Years.

National and international guidelines about thyroid surgery seem to be moving more and more towards less radical surgical procedures but everyday practice does not seem to always align with them. We describe for the first time the role of non-surgical parameters in the surgeon's choice for thyroid surgery. OBJECTIVE: The ain of this study was to describe thyroid surgery and to identify the factors leading to either a total or a partial thyroidectomy regardless of the severity of the thyroid disease. SUMMARY BACKGROUND DATA: National and international guidelines about thyroid surgery seem to be moving more and more toward less radical surgical procedures but everyday practice does not seem to always align with them. METHODS: We based this nationwide retrospective cohort study on a national database that compiles discharge abstracts for every admission for thyroidectomy to French acute healthcare facilities (PMSI database 2010 to 2019). RESULTS: In this study, 375,810 patients (male: 23%; age = 53 ±â€Š15 years) had a thyroidectomy (partial: 28%) for cancer (17%), hyperthyroidism (16%), nonfunctioning goiter (64%), or other (3%). We noticed a global trend toward more partial thyroidectomy (P < 0.001) with a significant increase in the proportion of lobectomy in the post-ATA recommendations' period (P < 0.001) as well as in the "French Levothyrox crisis" period, in which we saw an unexpected rise of adverse events notifications associated with the marketing of a new formula of Levothyrox (P < 0.001) amid widespread media coverage. In a multivariate analysis, we also identified that complete resection was more frequently performed in centers with a caseload >40/year [P < 0.001, odds ratio (OR) = 1.48], for obese patients (body mass index >30 kg/m2; P < 0.001, OR = 1.42), and according to the indication of surgery (OR benign = 1, OR cancer = 2.25, OR hyperthyroidism = 4.13). CONCLUSION: We describe for the first time the role of non-surgical parameters in the surgeon's choice for thyroid surgery.

Bariatric Surgery Provides Long-term Resolution of Nonalcoholic Steatohepatitis and Regression of Fibrosis.

BACKGROUND AND AIMS: Studies are needed to determine the long-term effects of bariatric surgery for patients with nonalcoholic steatohepatitis (NASH). We evaluated sequential liver samples, collected the time of bariatric surgery and 1 and 5 years later, to assess the long-term effects of bariatric surgery in patients with NASH. METHODS: We performed a prospective study of 180 severely obese patients with biopsy-proven NASH, defined by the NASH clinical research network histologic scores. The patients underwent bariatric surgery at a single center in France and were followed for 5 years. We obtained liver samples from 125 of 169 patients (76%) having reached 1 year and 64 of 94 patients (68%) having reached 5 years after surgery. The primary endpoint was the resolution of NASH without worsening of fibrosis at 5 years. Secondary end points were improvement in fibrosis (reduction of ≥1 stage) at 5 years and regression of fibrosis and NASH at 1 and 5 years. RESULTS: At 5 years after bariatric surgery, NASH was resolved, without worsening fibrosis, in samples from 84% of patients (n = 64; 95% confidence interval, 73.1%-92.2%). Fibrosis decreased, compared with baseline, in samples from 70.2% of patients (95% CI, 56.6%-81.6%). Fibrosis disappeared from samples from 56% of all patients (95% CI, 42.4%-69.3%) and from samples from 45.5% of patients with baseline bridging fibrosis. Persistence of NASH was associated with no decrease in fibrosis and less weight loss (reduction in body mass index of 6.3 ± 4.1 kg/m2 in patients with persistent NASH vs reduction of 13.4 ± 7.4 kg/m2; P = .017 with resolution of NASH). Resolution of NASH was observed at 1 year after bariatric surgery in biopsies from 84% of patients, with no significant recurrence between 1 and 5 years (P = .17). Fibrosis began to decrease by 1 year after surgery and continued to decrease until 5 years (P < .001). CONCLUSIONS: In a long-term follow-up of patients with NASH who underwent bariatric surgery, we observed resolution of NASH in liver samples from 84% of patients 5 years later. The reduction of fibrosis is progressive, beginning during the first year and continuing through 5 years.

Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.

BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 µs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.

IFNγ-producing NK cells in adipose tissue are associated with hyperglycemia and insulin resistance in obese women.

BACKGROUND/OBJECTIVES: Innate lymphoid cells (ILCs) play an important role in the maintenance of immune and metabolic homeostasis in adipose tissue (AT). The crosstalk between AT ILCs and adipocytes and other immune cells coordinates adipocyte differentiation, beiging, glucose metabolism and inflammation. Although the metabolic and homeostatic functions of mouse ILCs have been extensively investigated, little is known about human adipose ILCs and their roles in obesity and insulin resistance (IR). SUBJECTS/METHODS: Here we characterized T and NK cell populations in omental AT (OAT) from women (n = 18) with morbid obesity and varying levels of IR and performed an integrated analysis of metabolic parameters and adipose tissue transcriptomics. RESULTS: In OAT, we found a distinct population of CD56-NKp46+EOMES+ NK cells characterized by expression of cytotoxic molecules, pro-inflammatory cytokines, and markers of cell activation. AT IFNγ+ NK cells, but not CD4, CD8 or γδ T cells, were positively associated with glucose levels, glycated hemoglobin (HbA1c) and IR. AT NK cells were linked to a pro-inflammatory gene expression profile in AT and developed an effector phenotype in response to IL-12 and IL-15. Moreover, integrated transcriptomic analysis revealed a potential implication of AT IFNγ+ NK cells in controlling adipose tissue inflammation, remodeling, and lipid metabolism. CONCLUSIONS: Our results suggest that a distinct IFNγ-producing NK cell subset is involved in metabolic homeostasis in visceral AT in humans with obesity and may be a potential target for therapy of IR.

A tool to predict progression of non-alcoholic fatty liver disease in severely obese patients.

BACKGROUND & AIMS: Severely obese patients are a growing population at risk of non-alcoholic fatty liver disease (NAFLD). Considering the increasing burden, a predictive tool of NAFLD progression would be of interest. Our objective was to provide a tool allowing general practitioners to identify and refer the patients most at risk, and specialists to estimate disease progression and adapt the therapeutic strategy. METHODS: This predictive tool is based on a Markov model simulating steatosis, fibrosis and non-alcoholic steatohepatitis (NASH) evolution. This model was developped from data of 1801 severely obese, bariatric surgery candidates, with histological assessment, integrating duration of exposure to risk factors. It is then able to predict current disease severity in the absence of assessment, and future cirrhosis risk based on current stage. RESULTS: The model quantifies the impact of sex, body-mass index at 20, diabetes, age of overweight onset, on progression. For example, for 40-year-old severely obese patients seen by the general practitioners: (a) non-diabetic woman overweight at 20, and (b) diabetic man overweight at 10, without disease assessment, the model predicts their current risk to have NASH or F3-F4: for (a) 5.7% and 0.6%, for (b) 16.1% and 10.0% respectively. If those patients have been diagnosed F2 by the specialist, the model predicts the 5-year cirrhosis risk: 1.8% in the absence of NASH and 6.0% in its presence for (a), 10.3% and 26.7% respectively, for (b). CONCLUSIONS: This model provides a decision-making tool to predict the risk of liver disease that could help manage severely obese patients.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Risk Factors of Redo Surgery After Unilateral Focused Parathyroidectomy: Conclusions From a Comprehensive Nationwide Database of 13,247 Interventions Over 6 Years.

BACKGROUND: Surgical removal of hyperfunctional parathyroid gland is the definitive treatment for primary hyperparathyroidism (pHPT). Postoperative follow-up shows variability in persistent/recurrent disease rate throughout different centers. OBJECTIVE: To evaluate the incidence of redo surgery after targeted parathyroidectomy for pHPT. METHODS: We performed a nationwide retrospective cohort study on the "Programme de Medicalisation des Systemes d'Information," the French administrative database that collects information on all healthcare facilities' discharges. We extracted data from 2009 to 2018 for all patients who underwent parathyroidectomy for pHPT between January 2011 to December 2016. The primary outcome was the reoperation rate within 2 years since first surgery. Patients who had a first attempt of surgery within the previous 24 months, familial hyperparathyroidism, multiglandular disease, and renal failure were excluded. Results were adjusted according to sex and the Elixhauser Comorbidity Index. Operative volume thresholds to define high-volume centers were achieved by the Chi-Squared Automatic Interaction Detector method. RESULTS: In the study period, 13,247 patients (median age 63, F/M=3.6) had a focused parathyroidectomy by open (88.7%) or endoscopic approach. Need of remedial surgery was 2.8% at 2 years. In multivariate analysis, factors predicting redo surgery were: cardiac history (P=0.008), obesity (P=0.048), endoscopic approach (P=0.005), and low-volume center (P<0.001). We evaluated that an annual caseload of 31 parathyroidectomies was the best threshold to discriminate high-volume centers and carries the lowest morbidity/failure rate. CONCLUSION: Although focused parathyroidectomy represents a standardized operation, cure rate is strongly associated with annual hospital caseload, type of procedure (endoscopic), and patients' features (obesity, cardiac history). Patients with risk factors for redo surgery should be considered for an open surgery in a high-volume center.

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.

Adrenalectomy Risk Score: An Original Preoperative Surgical Scoring System to Reduce Mortality and Morbidity After Adrenalectomy.

OBJECTIVE: To explore the determinants of postoperative outcomes of adrenal surgery in order to build a proposition for healthcare improvement. SUMMARY OF BACKGROUND DATA: Adrenalectomy is the recommended treatment for many benign and malignant adrenal diseases. Postoperative outcomes vary widely in the literature and their determinants remain ill-defined. METHODS: We based this retrospective cohort study on the "Programme de médicalisation des systèmes d'information" (PMSI), a national database that compiles discharge abstracts for every admission to French acute health care facilities. Diagnoses identified during the admission were coded according to the French adaptation of the 10th edition of the International Classification of Diseases (ICD-10). PMSI abstracts for all patients discharged between January 2012 and December 2017 were extracted. We built an Adrenalectomy-risk score (ARS) from logistic regression and calculated operative volume and ARS thresholds defining high-volume centers and high-risk patients with the CHAID method. RESULTS: During the 6-year period of the study, 9820 patients (age: 55 ±â€Š14; F/M = 1.1) were operated upon for adrenal disease. The global 90-day mortality rate was 1.5% (n = 147). In multivariate analysis, postoperative mortality was independently associated with age ≥75 years [odds ratio (OR): 5.3; P < 0.001], malignancy (OR: 2.5; P < 0.001), Charlson score ≥2 (OR: 3.6; P < 0.001), open procedure (OR: 3.2; P < 0.001), reoperation (OR: 4.5; P < 0.001), and low hospital caseload (OR: 1.8; P = 0.010). We determined that a caseload of 32 patients/year was the best threshold to define high-volume centers and 20 ARS points the best threshold to define high-risk patients. CONCLUSION: High-risk patients should be referred to high-volume centers for adrenal surgery.

Impact of Centralized Management of Bariatric Surgery Complications on 90-day Mortality.

BACKGROUND AND AIMS: The potential benefit of the centralization of Bariatric surgery (BS) remains debated. The aim of this study was to evaluate the impact on 90-day mortality of an innovative organization aiming at centralizing the care of severe postoperative complications of BS. STUDY DESIGN: The centralization of care for postoperative complication after BS was implemented by French Authorities in 2013 in the Nord-Pas-de-Calais Region, France. This unique formalized network (OSEAN), coordinated by 1 tertiary referral center, enrolled all regional institutions performing bariatric surgery. Data were extracted from the medico-administrative database providing information on all patients undergoing BS between 2009 and 2016 in OSEAN (n = 22,928) and in Rest of France (n = 288,942). The primary outcome was the evolution of 90-day mortality before and after the implementation of this policy. Rest of France was used as a control group to adjust the results to improvement with time of BS outcomes. RESULTS: The numbers of primary procedure and reoperations increased similarly before and after 2013 within OSEAN and in Rest of France. The 90-day mortality rate became significantly lower within OSEAN than in the rest of France after 2013 (0.03% vs 0.08%, P < 0.01). This difference was confirmed in multivariate analysis after adjustment to the procedure specific mortality (P < 0.04). The reduction of 90-day mortality was most visible for sleeve gastrectomy. CONCLUSION: The implementation of centralized care for early postoperative complications after BS in OSEAN was associated with reduced 90-day mortality. Our results indicate that this reduction was not due to a lower incidence of complications but to the improvement of their management.