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Objective: This study aimed to survey international experts in metabolic and bariatric surgery (MBS) to improve and consolidate the management of biliary disease in patients with severe obesity undergoing MBS. Background: Obesity and rapid weight loss after MBS are risk factors for the development of gallstones. Complications, such as cholecystitis, acute cholangitis, and biliary pancreatitis, are potentially life-threatening, and no guidelines for the proper management of gallstone disease exist. Methods: An international scientific team designed an online confidential questionnaire with 26 multiple-choice questions. The survey was answered by 86 invited experts (from 38 different countries), who participated from August 1, 2023, to September 9, 2023. Results: Two-thirds of experts (67.4%) perform concomitant cholecystectomy in symptomatic gallstones during MBS. Half of experts (50%) would wait 6–12 weeks between both surgeries with an interval approach. Approximately 57% of the experts prescribe ursodeoxycholic acid (UDCA) prophylactically after MBS, and most recommend a 6-month course. More than the half of the experts (59.3%/53.5%) preferred laparoscopic assisted transgastric ERCP as the approach for treating CBD stones in patients who previously had RYGB/OAGB. Conclusion: Concomitant cholecystectomy is preferred by the experts, although evidence in the literature reports an increased complication rate. Prophylactic UDCA should be recommended to every MBS patient, even though the current survey demonstrated that not all experts are recommending it. The preferred approach for treating common bile duct stones is a laparoscopic assisted transgastric ERCP after gastric bypass. The conflicting responses will need more scientific work and clarity in the future. [ABSTRACT FROM AUTHOR]

Summary: The prevalence of nonalcoholic fatty liver disease (NAFLD) and the more severe and inflammatory type, nonalcoholic steatohepatitis (NASH), is increasing rapidly. Especially in high‐risk patients, that is those with obesity, metabolic syndrome, and type 2 diabetes mellitus, the prevalence of NAFLD can be as high as 80% while NASH may be present in 20% of these subjects. With the worldwide increase of obesity, it is most likely that these numbers will rise. Since advanced stages of NAFLD and NASH are strongly associated with morbidity and mortality—in particular, cardiovascular disease, liver cirrhosis, and hepatocellular carcinoma—it is of great importance to identify subjects at risk. A great variety of noninvasive tests has been published to diagnose NAFLD and NASH, especially using blood‐ and imaging‐based tests. Liver biopsy remains the gold standard for NAFLD/NASH. This review aims to summarize the different mechanisms leading to NASH and liver fibrosis, the different noninvasive liver tests to diagnose and evaluate patients with severe obesity. [ABSTRACT FROM AUTHOR]

Introduction Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). Methods and analysis This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. Ethics and dissemination The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. [ABSTRACT FROM AUTHOR]

Background: Morbidly obese patients are at higher risk of complications after surgery. In bariatric surgery, pre- and intra-operative checklists are commonly used to identify high-risk patients preoperatively, to decrease the number of postoperative complications. This pilot study evaluates the effect of a postoperative checklist in bariatric surgery, addressing regularly measured parameters, on the occurrence and early recognition of complications. Methods: An in-house developed postoperative checklist was used on the first postoperative day after bariatric surgery and included information on nausea, pain, temperature, heart rate, and laboratory markers. Complications were scored using the Clavien-Dindo (CD) classification, and three groups were formed: no complications (CD0), minor complications (CD1 and 2), and major complications (≥CD3a). Differences between groups were analyzed using nonparametric tests. Results: Six hundred ninety-four subjects were included (79.5% female, age 42.6 ± 10.8 years, BMI 43.8 ± 5.8 kg/m). Twenty-nine subjects developed major complications within 30 days postoperatively. There were no significant differences in baseline characteristics between groups. Subjects with major complications were less willing to be discharged due to complaints, compared to subjects with no or minor complications (14.8 vs. 3.6 and 4.6%, respectively) and had a higher decrease of hemoglobin level (0.8 vs. 0.6 and 0.65 mmol/l, respectively). Conclusion: The patient's willingness for discharge, in combination with hemoglobin decrease, may be the best early predictors of major complications after bariatric surgery. This postoperative checklist may be an adequate instrument to identify patients who can be safely discharged home on the first postoperative day and thereby play a part in patient management after bariatric surgery. [ABSTRACT FROM AUTHOR]

Background: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. Methods/Design: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life. Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life. The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life. Discussion: The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach. [ABSTRACT FROM AUTHOR]

Introduction: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery., Method and Analysis: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs., Ethics and Dissemination: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences., Trial Registration Number: NCT05464394., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The prevalence of non-alcoholic fatty liver disease (NAFLD) ranges from 25% in the general population to 90% in patients with obesity scheduled for bariatric surgery. NAFLD can progress towards non-alcoholic steatohepatitis (NASH) associated with complications such as cirrhosis, hepatocellular carcinoma and cardiovascular disease. To date, losing weight and lifestyle modifications are the best known treatments for NASH. Bariatric surgery significantly improves NAFLD/NASH in the short term. However, the extent of this improvement is not yet clear and long-term data on the natural course of NAFLD/NASH after bariatric surgery are lacking. The factors involved in NAFLD/NASH regression after bariatric surgery have not been elucidated., Methods and Analysis: This is an observational prospective cohort study including patients scheduled for bariatric surgery. Extensive metabolic and cardiovascular analyses will be carried out including measurements of carotid intima media thickness and pulse wave velocity. Genomic, proteomic, lipidomic and metabolomic studies will be done. Microbioma analyses before and 1 year after surgery will be done. Transient elastography measurements will be performed before and at 1, 3 and 5 years after surgery. For those with an elevated preoperative transient elastography measurement by Fibroscan, a laparoscopic liver biopsy will be performed during surgery. Primary outcome measures are the change of steatosis and liver fibrosis 5 years after surgery. Secondary outcome measure is the comparison of the transient elastography measurements with the NAFLD Activity Score from the biopsies., Ethics and Dissemination: The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 1 March 2022 (registration code R21.103/NL79423.100.21). The study results will be submitted for publication in peer-reviewed journals and data will be presented at scientific meetings., Trial Registration Number: NCT05499949., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB., Method and Analysis: This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m 2 ), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness., Ethics and Dissemination: The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations., Trial Registration Number: NL9789; The Netherlands Trial Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)