Unraveling factors associated with textbook outcome after cholecystectomy in patients with uncomplicated cholecystolithiasis: A posthoc analysis of individual data of 1,124 patients.

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.

Persistent and new-onset symptoms after cholecystectomy in patients with uncomplicated symptomatic cholecystolithiasis: A post hoc analysis of 2 prospective clinical trials.

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.

A mixed-methods study to define Textbook Outcome for the treatment of patients with uncomplicated symptomatic gallstone disease with hospital variation analyses in Dutch trial data.

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.

Patients with Clinically Suspected Gallstone Disease: A More Selective Ultrasound May Improve Treatment Related Outcomes.

This study aimed to quantify the confirmation of gallstones on ultrasound (US) in patients with suspicion of gallstone disease. To aid general practitioners (GPs) in diagnostic workup, a model to predict gallstones was developed. A prospective cohort study was conducted in two Dutch general hospitals. Patients (≥18 years) were eligible for inclusion when referred by GPs for US with suspicion of gallstones. The primary outcome was the confirmation of gallstones on US. A multivariable regression model was developed to predict the presence of gallstones. In total, 177 patients were referred with a clinical suspicion of gallstones. Gallstones were found in 64 of 177 patients (36.2%). Patients with gallstones reported higher pain scores (VAS 8.0 vs. 6.0, p < 0.001), less frequent pain (21.9% vs. 54.9%, p < 0.001), and more often met criteria for biliary colic (62.5% vs. 44.2%, p = 0.023). Predictors for the presence of gallstones were a higher pain score, frequency of pain less than weekly, biliary colic, and an absence of heartburn. The model showed good discrimination between patients with and without gallstones (C-statistic 0.73, range: 0.68-0.76). Clinical diagnosis of symptomatic gallstone disease is challenging. The model developed in this study may aid in the selection of patients for referral and improve treatment related outcomes.

Tailoring diagnosis and treatment in symptomatic gallstone disease.

BACKGROUND: There is a lack of consensus in selecting patients who do or do not benefit from surgery when patients present with abdominal pain and gallbladder stones are present. This review aimed to give an overview of results from recent trials and available literature to improve treatment decisions in patients with uncomplicated cholecystolithiasis. METHODS: First, an overview of different symptom criteria for laparoscopic cholecystectomy in patients with uncomplicated cholecystolithiasis is given, based on national and international guidelines. Second, treatment outcomes (absence of biliary colic, pain-free state, biliary and surgical complications) are summarized, with data from three clinical trials. Finally, personal advice for treatment decisions in patients with uncomplicated cholecystolithiasis is provided, based on recent trials, the available literature, and expert opinion. RESULTS: This review describes different guidelines and criteria sets for uncomplicated cholecystolithiasis, provides an overview of outcomes after cholecystectomy, and advises on treatment decisions in patients with abdominal pain and gallbladder stones. After cholecystectomy, biliary colic is resolved in 95 per cent of patients. However, non-specific abdominal pain persists in 40 per cent. Irritable bowel syndrome and functional dyspepsia significantly increase the risk of persistent pain. Age, previous abdominal surgery, baseline pain score on a visual analogue scale, pain characteristics, nausea, and heartburn are part of the SUCCESS criteria, and are associated with clinically relevant pain reduction after gallbladder removal. CONCLUSION: The surgical community can now give more personalized advice on surgery to improve care for patients with abdominal pain and uncomplicated cholecystolithiasis.

In primary care, more than 50 per cent of patients with ultrasonographically diagnosed gallbladder stones are diagnosed with concomitant abdominal disorders Laparoscopic cholecystectomy resolves biliary colic in 95 per cent of patients; however non-specific abdominal pain persists in up to 40 per cent Functional dyspepsia and irritable bowel syndrome significantly increase the risk of persistent pain after laparoscopic cholecystectomy Predictive factors for pain relief after cholecystectomy are older age, absence of previous surgery, pain characteristics, and absence of functional gastrointestinal disorders.

Cost-effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-trial).

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.

Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial).

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.

A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery.

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.

Budget Impact of Restrictive Strategy Versus Usual Care for Cholecystectomy (SECURE-Trial).

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.

Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design.

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Variation in practice and outcomes after inguinal hernia repair: a nationwide observational study.

BACKGROUND: Inguinal hernia repair has often been used as a showcase to illustrate practice variation in surgery. This study determined the degree of hospital variation in proportion of patients with an inguinal hernia undergoing operative repair and the effect of this variation on clinical outcomes. METHODS: A nationwide, longitudinal, database study was performed in all hospitals in the Netherlands between 2013 and 2015. Patients with inguinal hernias were collected from the Diagnosis-Related-Group (DRG) database. The case-mix adjusted operation rate in patients with a new DRG determines the observed variation. Hospital variation in case-mix adjusted inguinal hernia repair-rates was calculated per year. Clinical outcomes after surgery were compared between hospitals with high and low adjusted operation-rates. RESULTS: In total, 95,637 patients were included. The overall operation rate was 71.6%. In 2013-2015, the case-mix adjusted performance of inguinal hernia repairs in hospitals with high rates was 1.6-1.9 times higher than in hospitals with low rates. Moreover, in hospitals with high adjusted rates of inguinal hernia repair the time to surgery was shorter, more laparoscopic procedures were performed, less emergency department visits were recorded post-operatively, while more emergency department visits were recorded when patients were treated conservatively compared to hospitals with low adjusted operation rates. CONCLUSION: Hospital variation in inguinal hernia repair in the Netherlands is modest, operation-rates vary by less than two-fold, and variation is stable over time. Hernia repair in hospitals with high adjusted rates of inguinal hernia repair are associated with improved outcomes.

Hospital Variation in Cholecystectomies in The Netherlands: A Nationwide Observational Study.

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.

The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study.

OBJECTIVES: Obesity is a risk factor for several phenotypes such as gallstones, metabolic syndrome (MS), and nonalcoholic fatty liver disease (NAFLD). It has been suggested that cholecystectomy is a risk factor for metabolic abnormalities and NAFLD. We aimed to determine whether cholecystectomy is associated with MS or NAFLD in a Dutch population-based study. METHODS: The Rotterdam Study is an ongoing prospective population-based cohort. We included participants who underwent a liver ultrasound between 2009 and 2014 to assess steatosis. The prevalence of MS and NAFLD was calculated, and we performed regression analyses relating cholecystectomy with MS and NAFLD and adjusted for age, sex, study cohort, education level, physical activity, energy intake, time since cholecystectomy, body mass index, presence of hypertension, diabetes mellitus, and steatosis/MS. RESULTS: We included 4,307 participants (57.5% women, median age 66.0 years [interquartile range 58-74]). In total, 265 participants (6.2%) underwent a cholecystectomy. The median age at the time of cholecystectomy was 57.0 years (47.5-66.5), and the median time from cholecystectomy to imaging of the liver was 10.0 years (0.5-19.5). The prevalence of MS in participants with cholecystectomy was 67.2% and 51.9% in participants without cholecystectomy (P < 0.001). Ultrasound diagnosed moderate/severe NAFLD was present in, respectively, 42.7% and 34.2% of the participants (P = 0.008). After multivariable adjustments for metabolic factors, cholecystectomy was no longer associated with the presence of MS or NAFLD. DISCUSSION: The prevalence of MS and NAFLD is higher in participants after cholecystectomy. However, our trial shows that cholecystectomy may not be independently associated with the presence of MS and NAFLD after correction for metabolic factors.

The association between patients' preferred treatment after the use of a patient decision aid and their choice of eventual treatment.

OBJECTIVE: To investigate the association between patients' preferred treatment and eventual treatment. Second, to compare patients with surgical treatment to watchful waiting in order to identify predictive factors for surgery. METHODS: A single-centre retrospective study was performed between December 2015 and August 2018. Patients (≥18 years) who used a patient decision aid (PDA) for gallstones or inguinal hernia were included. After their first surgical consultation, patients received access to an online PDA. The patients' preferred treatment after the PDA was compared with their choice of eventual treatment. Multivariable regression analyses were performed for predictive factors for surgery. RESULTS: In total, 567 patients with gallstones and 585 patients with an inguinal hernia were included. Of the patients with gallstones, 121 (21%) preferred watchful waiting, 367 (65%) preferred surgery, and 79 (14%) were not sure. The patients' preferred treatment was performed in 85.9%. Frequent pain attacks (OR 2.1, 95% CI 1.1-3.9, P = .020) and preference for surgery (OR 4.4, 95% CI 1.9-10.1, P = .001) independently predicted surgery. Of the patients with an inguinal hernia, 77 (13.2%) preferred watchful waiting, 452 (78.8%) preferred surgery, and 56 (9.6%) were not sure. The patients' preferred treatment was performed in 86.0%. The preference for surgery (OR 5.2, 95% CI 2.5-10.6, P < .001) independently predicted surgery and worry about complications predicted avoidance of surgery (OR 0.5, 95% CI 0.2-1.0, P = .037). CONCLUSION: This study, reflecting current clinical care, shows that patients' preferred treatment after using a PDA matches their eventual treatment choice in 86% of patients with gallstones or an inguinal hernia. In these patients, symptoms and patients' preference for surgery independently predicts eventual choice of surgery.

Prevalence of dyspepsia in patients with cholecystolithiasis: a systematic review and meta-analysis.

Cholecystolithiasis and functional gastrointestinal disorders are both highly prevalent in the industrialized world and may exist concomitantly. The presence of both conditions impedes identification of the source of symptoms, leading to a risk of ineffective cholecystectomies with lack of symptom resolution. We carried out a systematic review and meta-analysis to determine the prevalence of dyspepsia in patients with uncomplicated cholecystolithiasis. The electronic databases Medline, Embase, and Web of Science were searched for articles reporting the prevalence of dyspepsia in adults (≥18 years) with uncomplicated cholecystolithiasis. Pooled prevalence and 95% confidence interval were calculated. I statistics were used to determine heterogeneity and the Methodological Evaluation of Observational Research criteria were applied for quality assessment. The study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Of the 1696 studies evaluated, 13 reported the prevalence of dyspepsia in a total of 1227 cholecystolithiasis patients seeking medical care. The pooled prevalence of dyspepsia in patients with cholecystolithiasis was 65.7% (95% confidence interval: 51-79%). However, heterogeneity was large across studies. Overall, three studies used validated diagnostic criteria. Variation in diagnostic measures significantly influenced the prevalence of dyspepsia. In conclusion, symptoms similar to those of functional gastrointestinal disorders are common in patients with cholecystolithiasis, obscuring the source of abdominal complaints. Tools to select patients who will benefit from cholecystectomy are paramount to prevent ineffective surgery.

Etiologies of Long-Term Postcholecystectomy Symptoms: A Systematic Review.

BACKGROUND: Cholecystectomy does not relieve abdominal symptoms in up to 40% of patients. With 700,000 cholecystectomies performed in the US, annually, about 280,000 patients are left with symptoms, making this a serious problem. We performed a systematic review to determine the different etiologies of long-term postcholecystectomy symptoms with the aim to provide guidance for clinicians treating these patients. METHODS: A systematic search of the literature was performed using MEDLINE, EMBASE, and Web of Science. Articles describing at least one possible etiology of long-term symptoms after a laparoscopic cholecystectomy were included in this review. Long-term symptoms were defined as abdominal symptoms that were present at least four weeks after cholecystectomy, either persistent or incident. The etiologies of persistent and incident symptoms after LC and the mechanism or hypothesis behind the etiologies are provided. If available, the prevalence of the discussed etiology is provided. RESULTS: The search strategy identified 3320 articles of which 130 articles were included. Etiologies for persistent symptoms were residual and newly formed gallstones (41 studies, prevalence ranged from 0.2 to 23%), coexistent diseases (64 studies, prevalence 1-65%), and psychological distress (13 studies, no prevalence provided). Etiologies for incident symptoms were surgical complications (21 studies, prevalence 1-3%) and physiological changes (39 studies, prevalence 16-58%). Sphincter of Oddi dysfunction (SOD) was reported as an etiology for both persistent and incident symptoms (21 studies, prevalence 3-40%). CONCLUSION: Long-term postcholecystectomy symptoms vary amongst patients, arise from different etiologies, and require specific diagnostic and treatment strategies. Most symptoms after cholecystectomy seem to be caused by coexistent diseases and physiological changes due to cholecystectomy. The outcome of this research is summarized in a decision tree to give clinical guidance on the treatment of patients with symptoms after cholecystectomy.

Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.

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%; pnon-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.

Reduced Elective Operation Rates and High Patient Satisfaction After the Implementation of Decision Aids in Patients with Gallstones or an Inguinal Hernia.

BACKGROUND: For both gallbladder removal and inguinal hernia repair, it is important to include patients' perspective in the decision-making process, as watchful waiting is an accepted alternative in selected patients. The aim of this study was to evaluate operation rates before and after implementation of decision aids (DAs) and to assess patient compliance with the use of DAs. METHODS: A single-centered retrospective study was performed, including all patients ≥18 years referred to the surgical outpatient clinic with symptomatic gallstones or an inguinal hernia between January 2014 and December 2017. Operation rates before and after implementation of DAs (December 2015) were compared. In addition, patient compliance with the use of DAs and satisfaction with final treatment were assessed. RESULTS: Overall, 1625 patients with gallstones and 1798 patients with an inguinal hernia were included. After implementation, DAs were provided to 512 patients (63.1%) with gallstones of whom 80.7% (413/512) used the DA and to 528 patients (58.8%) with an inguinal hernia, which was used by 80.7% (426/528). Before implementation, the operation rate in patients with gallstones was 72.0% (586/814) and after implementation 56.7% (460/811) (- 15.3%, p < 0.001). The operation rate in patients with an inguinal hernia decreased from 77.8% (700/900) to 64.6% (580/898) (- 13.2%, p < 0.001). Patient satisfaction with final treatment was high (9/10). CONCLUSION: Implementation of DAs in the surgical outpatient clinic for patients with gallstones or an inguinal hernia is associated with reduced elective operation rates and is associated with high DA compliance.