Preoperative Biliary Drainage in Patients with Obstructive Jaundice:History and Current Status

Preoperative biliary drainage (PBD) has been introduced to improve outcome after surgery in patients suffering from obstructive jaundice due to a potentially resectable proximal or distal bile duct/pancreatic head lesion. In experimental models, PBD is almost exclusively associated with beneficial results: improved liver function and nutritional status; reduction of systemic endotoxemia; cytokine release; and, as a result, an improved immune response. Mortality was significantly reduced in these animal models. Human studies show conflicting results. For distal obstruction, currently the "best-evidence" available clearly shows that routine PBD does not yield the appreciated improvement in postoperative morbidity and mortality in patients undergoing resection. Moreover, PBD harbors its own complications. However, most of the available data are outdated or suffer from methodological deficits. The highest level of evidence for PBD to be performed in proximal obstruction, as well as over the preferred mode, is lacking but, nevertheless, assimilated in the treatment algorithm for many centers. Logistics and waiting lists, although sometimes inevitable, could be factors that might influence the decision to opt for PBD, as well as an extended diagnostic workup with laparoscopy (on indication) or scheduled preoperative chemotherap

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE) : a multicentre, double-blind, randomised, placebo-controlled superiority trial

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 postrandomisation 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. Copyright (C) 2021 Elsevier Ltd. All rights reserved.Cellular mechanisms in basic and clinical gastroenterology and hepatolog

The effect of postoperative CPAP use on anastomotic and staple line leakage after bariatric surgery

© 2020, Springer Nature Switzerland AG.Purpose: Almost two-thirds of the population undergoing bariatric surgery (BS) suffers from obstructive sleep apnea (OSA). Continuous positive airway pressure (CPAP) is the standard treatment for moderate to severe OSA and is recommended in patients undergoing BS perioperatively. A severe and dreaded complication after BS is anastomotic leakage. There is theoretical concern that perioperative CPAP use may result in increased distension of the gastrointestinal tract and increase the risk of developing an anastomotic leakage. The aim of this study was to evaluate the effect of postoperative CPAP use on the risk of developing anastomotic leakages after BS. Methods: Retrospectively, all patients from a single bariatric center who underwent BS from November 2007 to August 2019 were included. Presence and severity of OSA were determined using poly(somno)graphy. To evaluate the effect of postoperative CPAP use on anastomotic leakage, a multivariable logistic regression analysis was performed. Results: A total of 4052 patients were included, with OSA being diagnosed in 62%. Overall, 970 patients (24%) used CPAP after BS. Anastomotic leakage occurred in 64 (1.6%) patients after BS. Leakage rate was 1.3% in non-CPAP group versus 2.5% in CPAP group (p = 0.01). CPAP use was associated with anastomotic leakage; however, after adjustment, CPAP use was not an independent predictor (OR = 1.40, 95% CI 0.60–3.28, p = 0.44). Conclusion: There is no independent relation between postoperative CPAP use and anastomotic leakage after BS. Only revision surgery was an independent predictor of anastomotic leakage

HollAND trial: comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids grade III: study protocol for a multicentre, randomised controlled trial and cost–utility analysis

Introduction Haemorrhoidal disease is one of the most common anorectal disorders, which affects nearly half of the general population. Treatment of grade III haemorrhoids consists initially of conservative measures, followed by rubber band ligation and haemorrhoidectomy when unsuccessful. Given the current guidelines and numerous modalities the obvious question which needs to be answered is which treatment is the best for grade III haemorrhoids. There is a need for evaluating treatment from the patient’s point of view and transparency in surgical and non-surgical treatment outcome.Methods and analysis This multicentre, randomised controlled, non-inferiority trial with cost–utility analysis compares haemorrhoidectomy with rubber band ligation. Patients aged 18 years and older with symptomatic haemorrhoids grade III are recruited. Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L and in-hospital (in)direct costs and out-of-hospital postoperative costs. A key secondary outcome is recurrence at 1-year postprocedure. Secondary outcomes are complaint reduction with proctology-specific patient-reported outcome measurements (Haemorrhoid Severity Score, ProctoPROM, PROM-HISS, vaizey score), resumption of work, pain and complication rates. Data are collected at seven different time points. Standard postprocedural care is followed.A sample size has been calculated using a one sided alpha of 0.025 and a power of 80% with an SD of 0.15 and a non-inferiority limit of 0.05. With stratification by centre and to adjust for 10% lost to follow-up the total sample size will be 360 patients in total (180 per group).Data will be analysed according to the intention-to-treat and the per-protocol principle.Ethics and dissemination The protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centres, location AMC. Findings will be disseminated in peer-reviewed journals and presented at conferences, whether they are positive, negative or inconclusive.Trial registration numbers NCT04621695, NTR802