Search

Importance: There is currently no consensus on the indication for cholecystectomy in patients with uncomplicated gallstone disease., Objective: To report on the development and validation of a multivariable prediction model to better select patients for surgery., Design, Setting, and Participants: This study evaluates data from 2 multicenter prospective trials (the previously published Scrutinizing (In)efficient Use of Cholecystectomy: A Randomized Trial Concerning Variation in Practice [SECURE] and the Standardized Work-up for Symptomatic Cholecystolithiasis [Success] trial) collected from the outpatient clinics of 25 Dutch hospitals between April 2014 and June 2019 and including 1561 patients with symptomatic uncomplicated cholelithiasis, defined as gallstone disease without signs of complicated cholelithiasis (ie, biliary pancreatitis, cholangitis, common bile duct stones or cholecystitis). Data were analyzed from January 2020 to June 2020., Exposures: Patient characteristics, comorbidity, surgical outcomes, pain, and symptoms measured at baseline and at 6 months' follow-up., Main Outcomes and Measures: A multivariable regression model to predict a pain-free state or a clinically relevant reduction in pain after surgery. Model performance was evaluated using calibration and discrimination., Results: A total of 1561 patients were included (494 patients in 7 hospitals in the development cohort and 1067 patients in 24 hospitals in the validation cohort; 6 hospitals included patients in both cohorts). In the development cohort, 395 patients (80.0%) underwent cholecystectomy. After surgery, 225 patients (57.0%) reported that they were pain free and 295 (74.7%) reported a clinically relevant reduction in pain. A multivariable prediction model showed that increased age, no history of abdominal surgery, increased visual analog scale pain score at baseline, pain radiation to the back, pain reduction with simple analgesics, nausea, and no heartburn were independent predictors of clinically relevant pain reduction after cholecystectomy. After internal validation, good discrimination was found (C statistic, 0.80; 95% CI, 0.74-0.84) between patients with and without clinically relevant pain reduction. The model had very good overall calibration and minimal underestimation of the probability. External validation indicated a good discrimination between patients with and without clinically relevant pain reduction (C statistic, 0.74; 95% CI, 0.70-0.78) and fair calibration with some overestimation of probability by the model., Conclusions and Relevance: The model validated in this study may help predict the probability of pain reduction after cholecystectomy and thus aid surgeons in deciding whether patients with uncomplicated cholelithiasis will benefit from cholecystectomy.

Background: International guidelines advise laparoscopic cholecystectomy to treat symptomatic, uncomplicated gallstones. Usual care regarding cholecystectomy is associated with practice variation and persistent post-cholecystectomy pain in 10-41% of patients. We aimed to compare the non-inferiority of a restrictive strategy with stepwise selection with usual care to assess (in)efficient use of cholecystectomy., Methods: We did a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals in the Netherlands. We enrolled patients aged 18-95 years with abdominal pain and ultrasound-proven gallstones or sludge. Patients were randomly assigned (1:1) to either usual care in which selection for cholecystectomy was left to the discretion of the surgeon, or a restrictive strategy with stepwise selection for cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who fulfilled all five pre-specified criteria of the triage instrument: 1) severe pain attacks, 2) pain lasting 15-30 min or longer, 3) pain located in epigastrium or right upper quadrant, 4) pain radiating to the back, and 5) a positive pain response to simple analgesics. Randomisation was done with an online program, implemented into a web-based application using blocks of variable sizes, and stratified for centre (academic versus non-academic and a high vs low number of patients), sex, and body-mass index. Physicians and patients were masked for study-arm allocation until after completion of the triage instrument. The primary, non-inferiority, patient-reported endpoint was the proportion of patients who were pain-free at 12 months' follow-up, analysed by intention to treat and per protocol. A 5% non-inferiority margin was chosen, based on the estimated clinically relevant difference. Safety analyses were also done in the intention-to treat population. This trial is registered at the Netherlands National Trial Register, number NTR4022., Findings: Between Feb 5, 2014, and April 25, 2017, we included 1067 patients for analysis: 537 assigned to usual care and 530 to the restrictive strategy. At 12 months' follow-up 298 patients (56%; 95% CI, 52·0-60·4) were pain-free in the restrictive strategy group, compared with 321 patients (60%, 55·6-63·8) in usual care. Non-inferiority was not shown (difference 3·6%; one-sided 95% lower CI -8·6%; p non-inferiority =0·316). According to a secondary endpoint analysis, the restrictive strategy resulted in significantly fewer cholecystectomies than usual care (358 [68%] of 529 vs 404 [75%] of 536; p=0·01). There were no between-group differences in trial-related gallstone complications (40 patients [8%] of 529 in usual care vs 38 [7%] of 536 in restrictive strategy; p=0·16) and surgical complications (74 [21%] of 358 vs 88 [22%] of 404, p=0·77), or in non-trial-related serious adverse events (27 [5%] of 529 vs 29 [5%] of 526)., Interpretation: Suboptimal pain reduction in patients with gallstones and abdominal pain was noted with both usual care and following a restrictive strategy for selection for cholecystectomy. However, the restrictive strategy was associated with fewer cholecystectomies. The findings should encourage physicians involved in the care of patients with gallstones to rethink cholecystectomy, and to be more careful in advising a surgical approach in patients with gallstones and abdominal symptoms., Funding: The Netherlands Organization for Health Research and Development, and CZ healthcare insurance., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. However, persistent pain after cholecystectomy for symptomatic cholecystolithiasis is reported in up to 40% of patients. The aim of the SECURE trial is to compare the effectiveness of usual care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. The SECURE trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound-proven gallstones or sludge. Randomization was performed to either usual care (standard practice, according to the physician's knowledge and experience, and physician's and patient's preference) or a restrictive standardized strategy: treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy based on fulfilment of pre-specified criteria. This article presents in detail the statistical analysis plan (SAP) of this trial and was submitted before outcomes were available to the investigators., Results: The primary end point of this trial is defined as the proportion of patients being pain-free at 12 months' follow-up. Pain will be assessed with the Izbicki Pain Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, quality of life, the association between the patients' symptoms and treatment, work performance, and cost-effectiveness., Discussion: The data from the SECURE trial will provide evidence whether or not a restrictive strategy in patients with symptomatic cholecystolithiasis is associated with similar patient reported outcomes and a reduction in the number of cholecystectomies compared to usual care. The data from this trial will be analyzed according to this pre-specified SAP., Trial Registration: The Netherlands National Trial Register NTR4022 . Registered on 5 June 2013.

Background: Multiple surgical techniques are recommended to perform cholecystectomy safely in difficult cases, such as conversion to open operation or subtotal cholecystectomy (STC). Reconstituting and fenestrating STC are 2 techniques for STC. The aim of this study was to investigate the short and long-term morbidity and quality of life associated with STC and to compare the outcomes after reconstituting and fenestrating STC., Study Design: Patients who underwent STC were identified. Short-term morbidity assessed included bile leakage, bile duct injury, intra-abdominal infection, reinterventions, and readmittance. Long-term morbidity included bile duct stenosis and recurrent biliary events. Differences in the outcomes of fenestrating and reconstituting STC were assessed. Quality of life was assessed by EuroQol 5 Dimensions, Short-Form 36 Questionnaire, and Gastrointestinal Quality of Life Index questionnaires., Results: Subtotal cholecystectomy was performed in 191 patients, of which 102 (53%) underwent fenestrating STC and 73 (38%) underwent reconstituting STC. Bile leakage was significantly more common after fenestrating STC (18% vs 7%, respectively; p < 0.022). After a median of 6 years follow-up (interquartile range 5 to 10 years), recurrence rate of biliary events was lower after fenestrating than reconstituting STC (9% vs 18%, respectively; p < 0.022). Overall reintervention rate did not differ between the 2 groups: 32% in the fenestrating STC group and 26% in the reconstituting STC group (p = 0.211). Completion cholecystectomy was performed significantly more in patients after fenestrating STC (9% vs 4%; p < 0.022)., Conclusions: Subtotal cholecystectomy is a safe and feasible technique for difficult cases for which conversion only will not solve the difficulty of an inflamed hepatocystic triangle. The choice for reconstituting or fenestrating STC depends on intraoperative conditions and both techniques are associated with specific complications., (Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Risk factors for conversion in cholecystectomy may be of clinical value. This study aimed to investigate whether a set of risk factors, including the surgeon's specialization, can be used for the development of a preoperative strategy to optimize conversion outcome., Methods: The data for all patients who underwent laparoscopic cholecystectomy at a single institution between January 2004 and December 2008 were retrospectively reviewed. Factors predictive for conversion were identified, and a preoperative strategy model was deduced., Results: Of the 1,126 patients analyzed, 106 (9%) underwent laparoscopic cholecystectomy in an emergency setting. Delayed surgery was performed for 63 (46%) of 138 patients (12%) with acute cholecystitis. Preoperative endoscopic retrograde cholangiography was achieved for 161 of the patients (14%). Risk factors predictive of conversion (for 65 patients) were male gender [odds ratio (OR), 2.3; 95% confidence interval (CI), 1.3-3.9; p = 0.004], age older than 65 years (OR, 2.6; 95% CI, 1.4-4.8; p = 0.002), body mass index (BMI) exceeding 25 kg/m(2) (OR, 3.4; 95% CI, 1.7-7.1; p < 0.001), history of complicated biliary disease (HCBD) (OR, 5.6; 95% CI, 3.2-9.8; p = < 0.001), and surgery by a non-gastrointestinal (non-GI) surgeon (OR, 4.9; 95% CI, 2.2-10.6; p < 0.001). The conversion rate for patients with a history of no complications who had two or more risk factors (gender, age, BMI > 25) and for patients with a HCBD who had one or more risk factors was significantly higher if the surgery was performed by non-GI rather than GI surgeons., Conclusion: Male gender, age older than 65 years, BMI exceeding 25 kg/m(2), HCBD, and surgery by a non-GI surgeon are predictive for conversion. A preoperative triage for surgeon selection based on risk factors and a HCBD is proposed to optimize conversion outcome.

Background: Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. Methods: This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay. Results: Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a noninferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P=0.010). No differences were observed in the number of other complications, or duration of hospital stay. Conclusion: Omitting antibiotic prophylaxis is not recommended. [ABSTRACT FROM AUTHOR]

Background & Aims: Patients with choledochocystolithiasis generally undergo endoscopic sphincterotomy (ES) followed by laparoscopic cholecystectomy (LC). However, many patients receive this surgery 6–8 weeks after ES. There is a high conversion rate of elective LC after ES, and patients can develop recurrent biliary events during the waiting period. We investigated whether the timing of surgery influences outcome. Methods: We performed a randomized trial of patients with choledochocystolithiasis who underwent successful ES. Patients were randomly assigned to groups that received early LC (within 72 hours after ES, n = 49) or delayed LC (after 6–8 weeks, n = 47), based on an expected difference in conversion rate of 25% vs 5%, respectively. Conversion rate, biliary events during follow-up, duration and difficulty of surgeries, postoperative morbidity, and hospital stay were scored. Intention-to-treat analyses were performed. Results: Groups were comparable in age, sex, and comorbidity. There was no difference between groups in conversion rate (4.3% in early vs 8.7% in delayed group) nor were there differences in operating times and/or difficulties or hospital stays. During the waiting period for LC, 17 patients in the delayed group (36.2%) developed recurrent biliary events compared with 1 patient in the early group (P < .001). Conclusions: In a randomized trial to evaluate timing of LC after ES, recurrent biliary events occurred in 36.2% of patients whose LC was delayed for 6–8 weeks. Early LC (within 72 hours) appears to be safe and might prevent the majority of biliary events in this period following sphincterotomy. [Copyright &y& Elsevier]

Background: Perforation of the gallbladder during laparoscopic cholecystectomy (LC) results in spill of bile or gallstones in the abdominal cavity. The aim of this study was to assess whether antibiotic agents after spill have an effect on post-operative and infectious complications. Patients and Methods: Operative reports and clinical data of patients undergoing LC between 2012 and 2016 in three hospitals were screened retrospectively for spill of bile and spill of gallstones. Included patients were divided into two groups: Patients who were treated with antibiotic agents (either prophylactic or a single administration during or directly post-operatively because of spill) and patients who did not receive any antibiotic agents. Patients were also categorized as to uncomplicated or complicated gallstone disease. Multi-variable logistic regression was used to assess risk factors for overall and infectious complications after spill. Results: Spill was reported in 14.7% (481 of 3,262). The infectious complication rate was 8.7% (42/481). Of 481 patients, 295 (61.3%) had uncomplicated gallstone disease and 239 (49.7%) received antibiotic treatment. Rates of infectious complications were comparable among patients receiving antibiotic agents or no antibiotic agents (8% vs. 9%, respectively; p = 0.779); also when analysis only included patients with complicated gallstone disease (11% vs. 10% respectively, p = 0.861). Spill of stones was the only independent risk factor associated with post-operative complications (odds ratio 2.55, 95% confidence interval 1.23-5.29, p = 0.012). Conclusion: Antibiotic agents (prophylaxis or intra-operative) after spill of bile and spill of gallstones do not reduce the risk of overall and infectious complications. Spill of stones is associated independently with post-operative complications. The present study sample may leave small differences in complication rates undetected. [ABSTRACT FROM AUTHOR]