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Objective: To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state. Summary Background Data: More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome. Methods: We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6 months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. Results: We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001. Conclusions: One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process. Trial Registration: The Netherlands Trial Register NTR-7307. Registered on 18 June 2018. [ABSTRACT FROM AUTHOR]

Importance: The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year., Objective: To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up., Design, Setting, and Participants: This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023., Interventions: Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy., Main Outcomes and Measures: The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction., Results: Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction., Conclusions and Relevance: In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes., Trial Registration: CCMO Identifier: NTR4022.

Background: A textbook outcome for the management of uncomplicated cholecystolithiasis is the targeted clinical scenario and is characterized by no recurrent biliary colic, absence of surgical and biliary complications, and absence or relief of abdominal pain. The aim of this study was to assess the incidence of textbook outcomes after cholecystectomy and identify associated baseline factors., Methods: Patients from 2 Dutch multicenter prospective trials between 2014 and 2019 (SECURE and SUCCESS trial) were included. The primary outcome was the proportion of patients with textbook outcomes after cholecystectomy at 6-month follow-up. Regression analysis was used to identify which factors before surgery were associated with textbook outcomes., Results: A total of 1,124 patients underwent cholecystectomy. A textbook outcome at 6-month follow-up was reached in 67.9% of patients. Persistent abdominal pain was the main reason for the failure to achieve textbook outcome. Patients who did achieve textbook outcomes more often reported severe pain attacks (89.4% vs 81.7%, P < .001) and/or biliary colic (78.6% vs 68.4%, P < .001) at baseline compared with patients without textbook outcomes. The presence of biliary colic at baseline (odds ratio = 1.56, 95% confidence interval: 1.16-2.09, P = .003) and nausea/vomiting at baseline (odds ratio = 1.33, 95% confidence interval: 1.01-1.74, P = .039) were associated with textbook outcome. The use of non-opioid analgesics (odds ratio = 0.76, 95% confidence interval: 0.58-0.99, P = .043) and pain frequency ≥1/month (odds ratio = 0.56, 95% confidence interval: 0.43-0.73, P < .001) were negatively associated with textbook outcome., Conclusion: Textbook outcome is achieved in two-thirds of patients who undergo cholecystectomy for uncomplicated cholecystolithiasis. Intensity and frequency of pain, presence of biliary colic, and nausea/vomiting at baseline are independently associated with achieving textbook outcomes. A more stringent selection of patients may optimize the textbook outcome rate in patients with uncomplicated cholecystolithiasis., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Laparoscopic cholecystectomy is the gold standard for treating biliary colic in patients with gallstones, but post-cholecystectomy abdominal pain is commonly reported. This study investigates which symptoms are likely to persist and which may develop after a cholecystectomy., Methods: Patients from 2 previous prospective trials who underwent laparoscopic cholecystectomy for symptomatic cholecystolithiasis were included. Patients completed questionnaires on pain and gastrointestinal symptoms before surgery and at 6 months follow-up. The prevalence of persistent and new-onset abdominal symptoms was evaluated., Results: A total of 820 patients received cholecystectomy and were included, 75.4% female (n = 616/820) mean age 49.4 years (standard deviation 13.7). At baseline, 74.1% (n = 608/820) of patients met all criteria for biliary colic. Cholecystectomy successfully resolved biliary colic in 94.8% (n = 327/345) of patients, but 36.5% (n = 299/820) of patients reported persistent abdominal pain after 6 months of follow-up. The prevalence of most abdominal symptoms reduced significantly. Symptoms such as flatulence (17.8%, n = 146/820) or restricted eating (14.5%, n = 119/820) persisted most often. New-onset symptoms were frequent bowel movements (9.6%, n = 79/820), bowel urgency (8.5%, n = 70/820), and new-onset diarrhea (8.4%, 69/820)., Conclusion: Postcholecystectomy symptoms are mainly flatulence, frequent bowel movements, and restricted eating. Newly reported symptoms are mainly frequent bowel movements, bowel urgency, and diarrhea. The present findings give clinical guidance in informing, managing, and treating patients with symptoms after cholecystectomy., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: International consensus on the ideal outcome for treatment of uncomplicated symptomatic gallstone disease is absent. This mixed-method study defined a Textbook Outcome (TO) for this large group of patients., Methods: First, expert meetings were organised with stakeholders to design the survey and identify possible outcomes. To reach consensus, results from expert meetings were converted in a survey for clinicians and for patients. During the final expert meeting, clinicians and patients discussed survey outcomes and a definitive TO was formulated. Subsequently, TO-rate and hospital variation were analysed in Dutch hospital data from patients with uncomplicated gallstone disease., Results: First expert meetings returned 32 outcomes. Outcomes were distributed in a survey among 830 clinicians from 81 countries and 645 Dutch patients. Consensus-based TO was defined as no more biliary colic, no biliary and surgical complications, and the absence or reduction of abdominal pain. Analysis of individual patient data showed that TO was achieved in 64.2% (1002/1561). Adjusted-TO rates showed modest variation between hospitals (56.6-74.9%)., Conclusion: TO for treatment of uncomplicated gallstone disease was defined as no more biliary colic, no biliary and surgical complications, and absence or reduction of abdominal pain.TO may optimise consistent outcome reporting in care and guidelines for treating uncomplicated gallstone disease., Competing Interests: Conflicts of interest Dr Drenth reports grants from Gilead outside the submitted work, paid to the Radboud University Medical Center., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objective: To perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain., Summary of Background Data: A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown., Methods: Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months., Results: All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with €160 per patient, €162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved €4563 from a societal perspective per pain-free patient lost., Conclusions: A restrictive selection strategy for cholecystectomy saves €162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of €4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective., Trial Registration: The Netherlands National Trial Register NTR4022. Registered on 5 June 2013., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups., Methods: Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30)., Results: Budget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%)., Conclusion: Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones., Trial Registration: The Netherlands National Trial Register NTR4022. Registered on June 5, 2013., (Copyright © 2021. Published by Elsevier Inc.)

Background: Practice variation generally raises concerns about the quality of care. This study determined the longitudinal degree of hospital variation in proportion of patients with gallstone disease undergoing cholecystectomy, while adjusted for case-mix, and the effect on clinical outcomes., Methods: A nationwide, longitudinal, database study was performed in all hospitals in the Netherlands in 2013-2015. Patients with gallstone disease were collected from the diagnosis-related group database. Hospital variation in case-mix-adjusted cholecystectomy rates was calculated per year. Clinical outcomes after cholecystectomy were compared between hospitals in the lowest/highest 20th percentile of the distribution of adjusted cholecystectomy rates in all 3 subsequent years., Results: In total, 96,673 patients with gallstones were included. The cholecystectomy rate was 73.6%. In 2013-2015, the case-mix-adjusted performance of cholecystectomies was in hospitals with high rates 1.5-1.6 times higher than in hospitals with low rates. Hospitals with a high adjusted cholecystectomy rate had a higher laparoscopy rate, shorter time to surgery, and less emergency department visits after a cholecystectomy compared to hospitals with a low-adjusted cholecystectomy rate., Conclusion: Hospital variation in cholecystectomies in the Netherlands is modest, cholecystectomy rates varies by <2-fold, and variation is stable over time. Cholecystectomies in hospitals with high adjusted cholecystectomy rates are associated with improved outcomes., (© 2020 The Author(s). Published by S. Karger AG, Basel.)