Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass at 5 years (YOMEGA): a prospective, open-label, non-inferiority, randomised extension study.

BACKGROUND: The multicentre randomised trial YOMEGA (NCT02139813) comparing the one anastomosis gastric bypass (OAGB) with the Roux-en-Y gastric bypass (RYGB) confirmed the non-inferiority of OAGB on weight loss outcomes at 24 months. We aimed to report weight loss, metabolic, and safety outcomes at 5 years. METHODS: YOMEGA is a prospective, open-label, non-inferiority, randomised trial conducted at nine centres in France. Inclusion criteria were BMI of 40 kg/m2 or more, or 35 kg/m2 or more with comorbidities. Key exclusion criteria were severe gastro-oesophageal reflux disease or Barrett's oesophagus and previous bariatric surgery. Patients were randomly assigned (1 :1) to OAGB (one gastrojejunal anastomosis with a 200 cm biliopancreatic limb) or RYGB (with a 150 cm alimentary limb and a 50 cm biliary limb), stratified by centre, with blocks of variable size. The primary endpoint of this extension study was percentage excess BMI loss and was analysed in the per-protocol population, including patients with data who were operated on with the technique randomly assigned to them and excluding patients with major deviations from the protocol during the follow-up (change of surgical technique, death, or withdrawal of consent). Non-inferiority was concluded for the primary endpoint if the upper bound of the CI was less than the non-inferiority limit (7 percentage points). YOMEGA is registered with ClinicalTrials.gov, NCT02139813, and the 5-year follow-up of YOMEGA is registered with ClinicalTrials.gov, NCT05549271. FINDINGS: Between May 13, 2014, and March 2, 2016, 253 patients were randomly assigned to OAGB (n=129) or RYGB (n=124), and from these patients 114 in the OAGB group and 118 in the RYGB group were included in the per-protocol analysis. In the per-protocol population, at baseline, mean age was 43·0 years (SD 10·8), mean BMI was 44·0 kg/m2 (5·6), 54 (23%) patients were male and 178 (77%) were female; 55 (27%) of 207 patients had type 2 diabetes. After 5 years, mean percentage excess BMI loss was -75·6% (SD 28·1) in the OAGB group versus -71·4% (SD 29·8) in the RYGB group, confirming non-inferiority (mean difference -4·1% [90% CI -12·0 to 3·7], p=0·0099). Remission of type 2 diabetes was similar in both groups. Nutritional status did not differ; the most common adverse event was clinical gastro-oesophageal reflux disease, occurring in 27 (41%) of 66 patients in the OAGB group versus 14 (18%) of 76 patients in the RYGB group (p=0·0030). Among serious adverse events, ten (8%) of 127 patients converted from OAGB to RYGB. 171 (68%) of 253 patients were followed up. INTERPRETATION: OAGB was not inferior to RYGB regarding percentage excess BMI loss at 5 years with similar metabolic outcomes. The high rate of clinical gastro-oesophageal reflux disease after OAGB raises questions about its long-term consequences, which need to be further investigated. FUNDING: Medtronic.

Bariatric surgery short-term outcomes in patients with obstructive sleep apnoea: the Severe Obesity Outcome Network prospective cohort.

BACKGROUND/OBJECTIVES: Although the benefits of bariatric surgery have been clearly established, it is not known whether they are as important in patients with obstructive sleep apnoea (OSA). Primary aim: to evaluate whether patients with moderate-to-severe OSA (apnoea-hypopnea index (AHI) ≥ 15 events/h) treated by continuous positive airway pressure/non-invasive ventilation (median [IQR] adherence 6.5 h/night [5; 7.9] at baseline) lose the same amount of body weight 1 year after bariatric surgery as patients with no or mild OSA. Secondary objectives: to compare the evolution of type 2 diabetes and hypertension after bariatric surgery, and surgical complication rates between groups. METHODS/SUBJECTS: Analyses were performed in 371 patients included in a prospective cohort of bariatric surgery, the Severe Obesity Outcome Network cohort. Subjects having moderate-to-severe OSA (n = 210) at baseline were compared with other subjects (n = 161). RESULTS: Excess weight loss (%EWL) at 1 year was lower in patients with moderate-to-severe OSA than in patients without (64.9%EWL [46.9; 79.5] vs. 73.8%EWL [56.6; 89.3], p < 0.01). Multivariable analysis showed that age, initial body mass index and type of surgery, but not OSA status, were associated with 1-year %EWL. Diabetes remitted in 25 (41%) patients with moderate-to-severe OSA and 16 (48%) patients with no or mild OSA (p = 0.48). Hypertension remitted in 28 (32.9%) patients with moderate-to-severe OSA and 9 (40.9%) with no or mild (p = 0.48). Complication rates were 28 (13.3%) in patients with moderate-to-severe OSA and 12 (7.5%) in patients with no or mild OSA (p = 0.07). CONCLUSIONS: Patients with OSA lose less body weight after bariatric surgery. This was related to older age and a higher baseline body mass index. However, the improvements of diabetes and hypertension were similar to that of patients without OSA, and the risk of surgical complications was not higher.

Explaining a model predicting quality of surgical practice: a first presentation to and review by clinical experts.

PURPOSE: Surgical Data Science (SDS) is an emerging research domain offering data-driven answers to challenges encountered by clinicians during training and practice. We previously developed a framework to assess quality of practice based on two aspects: exposure of the surgical scene (ESS) and the surgeon's profile of practice (SPP). Here, we wished to investigate the clinical relevance of the parameters learned by this model by (1) interpreting these parameters and identifying associated representative video samples and (2) presenting this information to surgeons in the form of a video-enhanced questionnaire. To our knowledge, this is the first approach in the field of SDS for laparoscopy linking the choices made by a machine learning model predicting surgical quality to clinical expertise. METHOD: Spatial features and quality of practice scores extracted from labeled and segmented frames in 30 laparoscopic videos were used to predict the ESS and the SPP. The relationships between the inputs and outputs of the model were then analyzed and translated into meaningful sentences (statements, e.g., "To optimize the ESS, it is very important to correctly handle the spleen"). Representative video clips illustrating these statements were semi-automatically identified. Eleven statements and video clips were used in a survey presented to six experienced digestive surgeons to gather their opinions on the algorithmic analyses. RESULTS: All but one of the surgeons agreed with the proposed questionnaire overall. On average, surgeons agreed with 7/11 statements. CONCLUSION: This proof-of-concept study provides preliminary validation of our model which has a high potential for use to analyze and understand surgical practices.

Effectiveness and Safety of Bariatric Surgery in Patients with End-Stage Chronic Kidney Disease or Kidney Transplant.

OBJECTIVE: This study aimed to evaluate (1) the effectiveness, complications, and postoperative access to transplantation in end-stage chronic kidney disease (ECKD) and (2) the effectiveness and complications of bariatric surgery in patients who had already undergone kidney transplant. METHODS: A systematic review and meta-analysis of mortality and complications rates were performed. Thirty studies were reviewed. RESULTS: After bariatric surgery, patients with ECKD had similar postoperative weight loss to patients from the general population. Meta-analysis showed post-bariatric surgery rates of 2% (95% CI: 0%-3%) for mortality and 7% (95% CI: 2%-14%) for complications. Approximately one-fifth of the patients had access to a transplant. This rate may be underestimated because of the short duration of follow-up. The lack of control groups did not allow for a conclusion on the role of bariatric surgery in facilitating access to kidney transplantation. In patients who had received a kidney transplant, bariatric surgery seemed to improve renal function but increased graft-rejection risk, possibly because of changes in the bioavailability of immunosuppressant drugs. CONCLUSIONS: Bariatric surgery yields significant weight loss in patients with ECKD that improves patients' chances of accessing a transplant but does not guarantee it; however, the risk for complications and death is higher than in other patients. After transplantation, bariatric surgery-induced weight loss appeared to positively impact the function of the grafted kidney, but careful monitoring of immunosuppressant medications is required.

Offline identification of surgical deviations in laparoscopic rectopexy.

OBJECTIVE: According to a meta-analysis of 7 studies, the median number of patients with at least one adverse event during the surgery is 14.4%, and a third of those adverse events were preventable. The occurrence of adverse events forces surgeons to implement corrective strategies and, thus, deviate from the standard surgical process. Therefore, it is clear that the automatic identification of adverse events is a major challenge for patient safety. In this paper, we have proposed a method enabling us to identify such deviations. We have focused on identifying surgeons' deviations from standard surgical processes due to surgical events rather than anatomic specificities. This is particularly challenging, given the high variability in typical surgical procedure workflows. METHODS: We have introduced a new approach designed to automatically detect and distinguish surgical process deviations based on multi-dimensional non-linear temporal scaling with a hidden semi-Markov model using manual annotation of surgical processes. The approach was then evaluated using cross-validation. RESULTS: The best results have over 90% accuracy. Recall and precision for event deviations, i.e. related to adverse events, are respectively below 80% and 40%. To understand these results, we have provided a detailed analysis of the incorrectly-detected observations. CONCLUSION: Multi-dimensional non-linear temporal scaling with a hidden semi-Markov model provides promising results for detecting deviations. Our error analysis of the incorrectly-detected observations offers different leads in order to further improve our method. SIGNIFICANCE: Our method demonstrated the feasibility of automatically detecting surgical deviations that could be implemented for both skill analysis and developing situation awareness-based computer-assisted surgical systems.

Benefits and risks of bariatric surgery in patients with bipolar disorders.

The prevalence of bipolar disorders in patients requesting bariatric surgery is estimated to be 1.5% to 3.4%. There are currently no specific recommendations regarding the way bariatric surgery should be managed in the context of bipolar disorder. The aim was to document the benefit-risk of bariatric surgery in patients with bipolar disorders. A systematic literature review was carried out. In addition, results were reported from a survey of current clinical practice in French referent centers for obesity care. Finally, 3 clinical cases from the "Severe Obesity Outcome Network" cohort are described. This systematic review shows there are few studies in the literature regarding the outcomes of bariatric surgery in patients with bipolar disorders and no randomized, controlled trials. Weight loss appeared similar in all patients, but psychiatric complications were sometimes reported in those with bipolar disorders. Almost all 11 referent centers for obesity care that responded had carried out bariatric surgery in patients with stable bipolar disorders. Postsurgical psychiatric destabilization occurred and included, at least, a need to reinforce treatment and follow-up. In the 3 case studies, postsurgical manic or hypomanic decompensation occurred. Thus, although effective in terms of weight loss, bariatric surgery could be a destabilizing factor for those with bipolar disorders. Current practice is to contraindicate surgery in patients with unstable disorders. There are insufficient data to conclude on the benefits and safety of bariatric surgery in patients with stable bipolar disease. Further studies are required to fully determine the benefits and risks.

Predicting the quality of surgical exposure using spatial and procedural features from laparoscopic videos.

PURPOSE : Evaluating the quality of surgical procedures is a major concern in minimally invasive surgeries. We propose a bottom-up approach based on the study of Sleeve Gastrectomy procedures, for which we analyze what we assume to be an important indicator of the surgical expertise: the exposure of the surgical scene. We first aim at predicting this indicator with features extracted from the laparoscopic video feed, and second to analyze how the extracted features describing the surgical practice influence this indicator. METHOD : Twenty-nine patients underwent Sleeve Gastrectomy performed by two confirmed surgeons in a monocentric study. Features were extracted from spatial and procedural annotations of the videos, and an expert surgeon evaluated the quality of the surgical exposure at specific instants. The features were used as input of a classifier (linear discriminant analysis followed by a support vector machine) to predict the expertise indicator. Features selected in different configurations of the algorithm were compared to understand their relationships with the surgical exposure and the surgeon's practice. RESULTS : The optimized algorithm giving the best performance used spatial features as input ([Formula: see text]). It also predicted equally the two classes of the indicator, despite their strong imbalance. Analyzing the selection of input features in the algorithm allowed a comparison of different configurations of the algorithm and showed a link between the surgical exposure and the surgeon's practice. CONCLUSION : This preliminary study validates that a prediction of the surgical exposure from spatial features is possible. The analysis of the clusters of feature selected by the algorithm also shows encouraging results and potential clinical interpretations.

Assessment of haemorrhoidal artery network using Doppler-guided haemorrhoidal artery ligation for haemorrhoids and pathogenesis implications.

BACKGROUND: Some authors, either with anatomical studies or Doppler laser flowmetric investigations have shown the blood flow to the posterior midline of the anus to be potentially deficient. This relative local ischaemia might explain pathogenesis of anal fissure, which is often located posteriorly. The aim of this study was to record the exact position of the distal branches of the superior rectal artery during Doppler-guided haemorrhoidal artery ligation-rectoanal repair (HAL-RAR) procedures with special reference to posterior distribution of the arteries. METHODS: All consecutive patients with symptomatic haemorrhoids who were treated with the HAL-RAR procedure between February 2008 and February 2014 in a single institution were included in the study. Number and position of Doppler-guided ligations were prospectively collected. Pearson's chi-squared test was used to compare artery locations. RESULTS: A total of 150 patients (75 women) with symptomatic haemorrhoids were included in the study. Median age was 53 years (range 23-83). A median of 10 ligations were placed per patient (range 3-18). A significantly lower number of cumulative arterial ligations was recorded in the posterior position (88 ligations overall, P = 0.025). CONCLUSIONS: The number of distal branches of the superior rectal artery that have been localized by the Doppler-guided HAL-RAR technique is lower at the posterior midline than in the other segments of the lower rectum. This is another evidence of the vascular deficiency at the posterior pole of the anal canal that might explain the pathogenesis of the anal fissure.

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.

Waist, neck circumferences, waist-to-hip ratio: Which is the best cardiometabolic risk marker in women with severe obesity? The SOON cohort.

METHODS: Data from women (n = 305, aged 43 [34; 53] years-old, BMI 44.2 [40.8; 48.2] kg/m2) included in the Severe Obesity Outcome Network (SOON) cohort were analyzed (i) to evaluate collinearity between the different anthropometric markers, (ii) to compare the association of markers with hypertension, type 2 diabetes, obstructive sleep apnea syndrome (OSAS) and other cardiometabolic risks. RESULTS: Hip, waist and neck circumferences correlated with BMI with respectively less collinearity (r = 0.70, r = 0.59 and r = 0.37, respectively, p<0.001) whereas waist-to-hip ratio was not correlated (r = 0.11, p = 0.072). Waist and neck circumferences were significantly associated with hypertension, type 2 diabetes and OSAS in univariate logistic regressions, waist-to-hip ratio with hypertension and type 2 diabetes. Hip circumference was inversely correlated with type 2 diabetes (OR 0.970 (95CI: 0.948; 0.991) p = 0.006). BMI was only linked to OSAS (OR 1.092 (95CI: 1.043; 1.143) p<0.001). Neck circumference was the only marker significantly associated with all cardiometabolic risk markers (HOMA-IR, apnea-hypopnea index, Log Triglycerides/HDL-c, alanin-aminotransferase, aspartate-aminotransferase, gammaglutamyl transpeptidase). CONCLUSIONS: Neck circumference appears the most appropriate anthropometric marker to identify the fat distribution associated with high cardiometabolic risk in women with severe obesity.

Bariatric surgery improves the employment rate in people with obesity: 2-year analysis.

BACKGROUND: Beyond medical complications, people with obesity experience dramatic impairment of quality of life, including adverse workplace effects. Obesity results in weight-based discrimination and a high rate of unemployment because of work disability, absenteeism, loss of productivity, and cost. A few studies have been performed to assess the relationship between obesity surgery and the workplace, finding an improvement in weekly working hours and productivity and a decrease in absenteeism, days of sick leave, and state benefit claims. However, the results are still controversial concerning the overall employment rate. OBJECTIVES: This study aimed to compare the employment rate before and 2 years after obesity surgery and to evaluate the difference in weight loss between worker and nonworker patients. SETTING: Participants were recruited from a tertiary care university hospital in France. METHODS: The 2-year outcomes of all patients who underwent obesity surgery between 2010 and 2015 were retrospectively reviewed. The employment status was recorded preoperatively and postoperatively. Retired or permanently disabled patients were excluded from the analysis. RESULTS: Preoperatively, 158 of 238 patients were employed compared with 199 of 238 postoperatively (P < .0001). There was no difference in weight loss between the worker and nonworker patients regarding the percentage of excess weight loss and the change in body mass index. CONCLUSION: This study supports the finding that bariatric surgery also has a positive impact on the professional sphere, providing the opportunity for unemployed patients to return to work.

Prevalence and Factors Associated with Helicobacter Pylori in Patients Undergoing Bariatric Surgery: the SOON Cohort.

PURPOSE: Helicobacter Pylori (HP) infection is systematically screened for before carrying out bariatric surgery. Criteria to determine "at risk" patients and avoid systematic screening are lacking. We evaluated the prevalence of HP infection and associated predictive factors in a population of patients with class II and III obesity volunteering for bariatric surgery. MATERIALS AND METHODS: Observational, cross-sectional study of patients included in the severe obesity outcome network (SOON) cohort. All patients underwent HP screening. The relationship between plasma metabolic parameters and vitamin levels, medical history and socio-economic parameters, and HP infection was analyzed. RESULTS: Data from 201 patients, median age 43 years [IQR 35; 52] (81% female) were analyzed. Forty-four patients (22%) were infected with HP and successfully treated, most with a single course of treatment, either combined antibiotics or Pylera®. HP infection was associated with social precariousness as defined by the French "Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé" (EPICES) score (Evaluation of Poverty and Health Inequalities in Health-Assessment Centers) (OR, 1.027; 95% CI, 1.008-1.046; p < 0.004) and with higher levels of vitamin B12 (OR, 1.004; 95% CI, 1.001-1.007; p < 0.007). CONCLUSION: The prevalence of HP infection was 22% and was associated with social precariousness. Plasma glucose/insulin and lipid/lipoprotein profiles, liver enzymes or vitamin deficiencies were not associated with HP infection. The number of characteristics associated with HP infection was insufficient to define patients who do not require HP screening before bariatric surgery.

Benefit-risk of intraoperative liver biopsy during bariatric surgery: review and perspectives.

Nonalcoholic fatty liver disease (NAFLD) is a metabolic complication of obesity that encompasses a spectrum of conditions, including hepatic steatosis, nonalcoholic steatohepatitis (NASH), cirrhosis, and end-stage liver disease. Screening for NAFLD is important to limit progression, allow early detection of carcinoma, and follow the need for liver transplantation. Although noninvasive markers exist, hepatic histologic evaluation remains the gold standard for diagnosis. To reduce the risk of complications after liver biopsy but increase the accuracy of NAFLD diagnosis, hepatic tissue can be sampled during bariatric surgery. This practice raises the question whether liver biopsies should be systematically carried out intraoperatively to screen for NAFLD or limited to patients who have positive results for noninvasive markers of NASH. The aim of this systematic review was to determine the prevalence of NASH in patients with obesity undergoing bariatric surgery, the performance of noninvasive markers of NASH and complications of intraoperative liver biopsy. Meta-analysis found an overall NASH prevalence of .25 (95% confidence interval, .12-.39), with a high level of heterogeneity (I2 = 97%) across studies. The review showed that each noninvasive marker alone was unable to discriminate between patients with a normal liver and others. Conversely, intraoperative biopsy was related to some complications. Results from a clinical practices questionnaire in specialized centers for obesity care in France showed a large degree of heterogeneity. A prospective study would be interesting to evaluate an algorithm based on noninvasive markers for clinical decision making to determine the pertinence of liver biopsy during bariatric surgery.

Malnutrition after bariatric surgery.

BACKGROUND: Malnutrition is a rare but severe complication following obesity surgery. Our objective was to analyze these cases of malnutrition and their management at the Grenoble University Hospital. METHODS: Retrospective data between 2006 to 2016 was analyzed from Department of Medical Information, Severe Obesity Outcome Network, and register of the Department of Artificial Nutrition. Data collected concerned age, sex, anthropometric data, surgical procedures and history of obesity surgery, initial surgical follow-up, delay from surgery, nutritional characteristics, nutritional and surgical management, follow-up and outcomes. RESULTS: Six patients had protein malnutrition after obesity surgery. Five patients (N.=5/6 83%) were initially operated on in other establishments. Only 1 patient in the cohort of 484 patients operated at on our institution was suffering from malnutrition (N.=1/484, 0.2%). All patients showed an excess weight loss of over 100%. Albumin level averaged 24.8 g/L at time of diagnosis. Patients were mainly operated on for an omega bypass (N.=4/6, 66%). Delay of malnutrition was 17.25 months in this category of patients whereas it was 84 months in patients having been operated on by another intervention. 3 patients (i.e. 50%) had chronic kidney disease when their initial surgery was performed. Two patients presented acute idiopathic pancreatitis following obesity surgery. CONCLUSIONS: Patients are at risk of malnutrition, especially after omega bypass and in patients with chronic kidney disease. Occurrence of acute pancreatitis is an alert to the risk of malnutrition.