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Background: Rapid weight loss is a major risk factor for the formation of cholesterol gallstones. Consequently, patients with morbid obesity undergoing bariatric surgery frequently develop symptomatic gallstone disease. This trial assessed the efficacy of ursodeoxycholic acid versus placebo for the prevention of symptomatic gallstone disease after bariatric surgery., Methods: This multicentre, double-blind, randomised, placebo-controlled superiority trial enrolled patients with an intact gallbladder scheduled for laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy in three hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module to receive 900 mg ursodeoxycholic acid daily for 6 months or matched placebo. Randomisation was stratified by the presence of asymptomatic gallstones at baseline and type of surgery. Patients, clinicians, and study staff were masked to treatment allocation. The primary endpoint was symptomatic gallstone disease within 24 months, assessed in the modified intention-to-treat population (all randomly assigned eligible patients with any post-randomisation measurement). Prespecified subgroup analyses were done based on the stratification groups. Safety was assessed in all patients who took at least one dose of the study drug. This trial is registered with the Netherlands Trial Register, NL5954., Findings: Between Jan 11, 2017, and Oct 22, 2018, 985 patients were randomly assigned to receive either ursodeoxycholic acid (n=492) or placebo (n=493). 967 patients were included in the modified intention-to-treat population, of whom 959 had data available for primary endpoint assessment. 189 (20%) patients had asymptomatic gallstones at baseline and 78 (8%) received a sleeve gastrectomy. Symptomatic gallstone disease occurred in 31 (6·5%) of 475 patients in the ursodeoxycholic acid group and in 47 (9·7%) of 484 patients in the placebo group (relative risk 0·67, 95% CI 0·43-1·04, p=0·071). Logistic regression showed a significant interaction between ursodeoxycholic acid and the presence of asymptomatic gallstones at baseline (p=0·046), with an effect of ursodeoxycholic acid in patients without (0·47, 0·27-0·84, p=0·0081), and no effect in patients with asymptomatic gallstones at baseline (1·22, 0·61-2·47, p=0·57). The effect was stronger in patients without gallstones at baseline undergoing RYGB (0·37, 0·20-0·71, p=0·0016), whereas the subgroup of patients undergoing sleeve gastrectomy was too small to draw clear conclusions. Adverse events were rare. In the ursodeoxycholic acid group, diarrhoea occurred in four (0·9%) of 444 patients and skin rash in two (0·5%) patients. In the placebo group, diarrhoea occurred in two (0·4%) of 453 patients and skin rash in two (0·4%) patients. The total number of serious adverse events did not significantly differ between the trial groups (75 [17%] in 444 patients in the ursodeoxycholic acid group and 102 [23%] in 453 patients in the placebo group). The most common serious adverse events were abdominal pain and internal hernia. No serious adverse event was attributed to the study drug., Interpretation: Ursodeoxycholic acid prophylaxis did not significantly reduce the occurrence of symptomatic gallstone disease in all patients after bariatric surgery. In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease compared with placebo. Further research is needed to assess the efficacy of ursodeoxycholic acid after sleeve gastrectomy., Funding: The Netherlands Organization for Health Research and Development, Zambon Netherlands BV, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism., Competing Interests: Declaration of interests PF reports a grant from the Netherlands Organization for Health Research and Development, during the conduct of the trial. VEAG reports grants from the Foundation for Clinical Research of the Slotervaart Hospital and the Spaarne Gasthuis Academy, during the conduct of the trial. RPV reports grants from Amsterdam Gastroenterology Endocrinology Metabolism, during the conduct of the trial. Zambon Netherlands BV provided trial materials consisting of all ursodeoxycholic acid tablets and an ultrasonography device. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Long-term follow-up with blood tests is essential for bariatric surgery to be a successful treatment for obesity and related co-morbidities. Adverse effects, deficiencies, and metabolic improvements need to be controlled., Objective: We investigated the effects of time and weight loss on laboratory results in each postoperative phase after laparoscopic Roux-en-Y gastric bypass (LRYGB)., Setting: Bariatric center of excellence, general hospital, Netherlands., Methods: We retrospectively evaluated results of 30 blood tests, preoperatively and at 6 months, 1 year, 2 years, and 5 years after LRYGB. The 2019 Dutch bariatric chart was used to define weight loss responses as outstanding (>p[percentile curve]+1 SD), average (p+1 SD to p-1 SD), and poor (

Background: Patients who have undergone bariatric surgery are at risk for subsequent cholecystectomy. We aimed to identify risk factors for cholecystectomy after laparoscopic Roux-en-Y gastric bypass (LRYGB)., Methods: We conducted a retrospective case-control study of patients who underwent LRYGB between 2013 and 2015. Cases underwent cholecystectomy because of biliary symptoms after LRYGB. For each case, two controls were selected without subsequent cholecystectomy. Logistic regression analyses were used to identify risk factors., Results: Between 2013 and 2015, 1780 primary LRYGBs were performed. We identified 233 (13.1%) cases who had undergone cholecystectomy after a median (IQR) of 12 (8-17) months, and 466 controls. Female gender (OR (95% CI) 1.83 (1.06-3.17)), Caucasian ethnicity (OR (95% CI) 1.82 (1.10-3.02)), higher percent total weight loss (%TWL) at 12 months (OR (95% CI) 1.06 (1.04-1.09)), and preoperative pain syndrome (OR (95% CI) 2.72 (1.43-5.18)) were significantly associated with an increased risk for cholecystectomy. Older age (OR (95% CI) 0.98 (0.96-0.99)) and preoperative statin use were associated with a reduced risk (OR (95% CI) 0.56 (0.31-1.00)). A dose-effect relationship was found between the intensity of preoperative statin and risk for cholecystectomy., Conclusions: In our study, higher %TWL and preoperative pain syndrome were associated with an increased risk for cholecystectomy besides the traditional risk factors female gender and Caucasian ethnicity. These factors can be used to identify high-risk patients, who might benefit from preventive measures. Whether statins can protect bariatric patients from developing gallstones should be investigated prospectively.

Background: Roux-en-Y gastric bypass (RYGB) is an effective treatment for morbid obesity, but many patients have increased gastrointestinal symptoms., Objectives: To evaluate gastrointestinal symptoms and food intolerance before and after RYGB over time in a large cohort of morbidly obese patients., Setting: A high-volume bariatric center of excellence., Methods: A prospective cohort study was performed in patients who underwent RYGB between September 2014 and July 2015, with 2-year follow-up. Consecutive patients screened for bariatric surgery answered the Gastrointestinal Symptom Rating Scale (GSRS) and a food intolerance questionnaire before RYGB and 2 years after surgery. The prevalence of gastrointestinal symptoms before and after surgery and the association between patient characteristics and postoperative gastrointestinal symptoms were assessed., Results: Follow-up was 86.2% (n = 168) for patients undergoing primary RYGB and 93.3% (n = 28) for revisional RYGB. The total mean GSRS score increased from 1.69 to 2.31 after surgery (P < .001), as did 13 of 16 of the individual scores. Preoperative GSRS score is associated with postoperative symptom severity (B = .343, P < .001). Food intolerance was present in 16.1% of patients before primary RYGB, increasing to 69.6% after surgery (P < .001). Patients who underwent revisional RYGB had a symptom severity and prevalence of food intolerance comparable with that among patients with primary RYGB, even though they had more symptoms before revisional surgery., Conclusions: Two years after surgery, patients who underwent primary RYGB have increased gastrointestinal symptoms and food intolerance compared with the preoperative state. It is important that clinicians are aware of this and inform patients before surgery., (Copyright © 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Enhanced recovery after surgery (ERAS) programmes have led to a decreased duration of hospital stay in several surgical fields, but have not been fully tested in patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) for obesity. This study aimed to investigate an ERAS programme versus standard care in these patients., Methods: Between January 2013 and July 2014, patients undergoing LRYGB were randomized to ERAS or conventional care. The primary outcome was functional hospital stay, defined as the time between end of surgery and when predefined discharge criteria (pain adequately controlled, fever and postoperative nausea and vomiting (PONV) absent, full liquid diet tolerated, mobilized and feeling fit for discharge) were met. Secondary outcomes were total length of hospital stay, 30-day complication and mortality rates, duration of surgery, time spent on the recovery ward and health-related quality of life., Results: A total 220 patients were randomized to ERAS (110 patients) or conventional (110) care. Patients in the ERAS group had shorter functional hospital stay (17·4 versus 20·5 h; P  < 0·001), quicker pain control, tolerated liquid diet earlier, had earlier control of PONV, mobilized sooner and were comfortable with discharge sooner than those receiving conventional care. Total length of hospital stay, duration of surgery, time spent on the recovery ward, health-related quality of life, complication and readmission rates did not differ between the study groups. There were no deaths., Conclusion: Patients under ERAS care recovered faster after LRYGB surgery than those receiving conventional care, with no increase in readmission and postoperative morbidity rates. Registration number: NTR3853 (http://www.trialregister.nl/).

Background: Staple line leakage after bariatric surgery can be treated by endoscopic placement of a self-expandable stent. The success rate of stent placement is generally high, but migration is a frequent adverse event that hampers successful treatment. The Niti-S Beta stent is a fully covered double-bump stent that was specifically designed to prevent migration. This study aimed to evaluate the effectiveness and adverse event rate of the Niti-S Beta stent., Methods: A retrospective study was performed in three high-volume bariatric centers. All consecutive patients between 2009 and 2016 who underwent placement of a Beta stent for staple line leakage were included. Primary outcome was resolution of the leakage; secondary outcome was the adverse event rate including migration., Results: Thirty-eight patients were included. Twenty-five (66%) had resolution of the leakage. Success rate was higher in patients who were treated with implantation of a Beta stent as initial treatment (100%) than in patients who were treated with a stent after revisional surgery had failed (55%, p = 0.013). Migration occurred in 12 patients (32%). There were two severe adverse events requiring surgical intervention, including a bleeding from an aorto-esophageal fistula., Conclusions: The success rate and the migration rate of the Beta stent seem comparable to other stents in this retrospective study. Despite the novel double-bump structure of the stent, the migration rate does not seem to be decreased.

Background: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA., Methods: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed., Discussion: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective., Trial Registration: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

Background: Even in a large volume bariatric centre, bariatric surgeons are sometimes confronted with intraoperative anatomical challenges which force even the most experienced surgeon into a pioneering position. In this video we present how a large gap of approximately 8 cm is bridged by applying several techniques that are not part of our standardized surgical procedure., Case Presentation: After creation of a 20 mL gastric pouch we discovered that the alimentary limb could not be advanced further cranially due to a very short a thick jejunal mesentery in a 49 year old male patient during laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery. By dissecting the gastro-oesophageal junction form the crus, stretching the gastric pouch, transecting the jejunal mesentery, using a retrocolic/retrogastric route, and creating a fully hand-sewn gastrojejunostomy we were able to safely complete the LRYGB. Drains were left near the gastrojejunostomy and the patient was kept nil by mouth for 5 days. On the 5th postoperative day radiographic swallow series were obtained which revealed no sign of leakage. The patient was discharged in good clinical condition on the 6th postoperative day. To date, no complications have occurred. Weight loss results are -31.5 % of the preoperative total body weight., Conclusions: When confronted with a large distance between the gastric pouch and the alimentary limb, several techniques presented in this video may be of aid to the bariatric surgeon. We stress that only experienced bariatric surgeon should embark on these techniques. Inspecting the alimentary limb before the creation of the gastric pouch may prevent the need for such complex techniques.