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

Latenstein, Carmen S S; Hannink, Gerjon; Bilt, Jarmila D. W. van der; Donkervoort, Sandra; Eijsbouts, Q. A. J.; Heisterkamp, Joos; Nieuwenhuijs, Vincent B.; Schreinemakers, Jennifer M. J.; Wiering, Bastiaan; Boermeester, Marja A.; Drenth, Joost P.H.; Laarhoven, Cornelis J. H. M. van; Dijkgraaf, Marcel G. W.; Reuver, Philip R. de

doi:10.1001/jamasurg.2021.3706

Cited by 19 publications

(14 citation statements)

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“…The variables included in this tool illustrate that patient characteristics, pain scores, surgical history and signs of functional gastrointestinal disorders are more the relevant factors to predict clinically relevant pain reduction after surgery. 17 Cholecystectomy is indicated for complicated gallstone disease (eg, cholecystitis, biliary pancreatitis), while consensus among surgeons and gastroenterologists for the selection for cholecystectomy in uncomplicated gallstone disease is absent. 18 Underlying gastrointestinal disorders such as dyspepsia, heartburn, regurgitation or constipation hamper the outcome of cholecystectomy.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…17 general practices affiliated with the Radboud University Medical Centre Practice Based Research Network in Nijmegen, the Netherlands. Subsequently, for in-depth analysis, we studied data from the medical records in a subset of seven affili-…”

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Healthcare utilisation of patients with cholecystolithiasis in primary care: a multipractice comparative analysis

et al. 2021

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ObjectivesTo examine general practitioners’ (GP) management of cholecystolithiasis and to evaluate persisting abdominal complaints in the years after the diagnosis.DesignRetrospective analysis of registry data and a subset of individual medical records.SettingSeventeen primary care practices affiliated with the Radboudumc Practice Based Research Network in the Netherlands.Participants633 patients with cholecystolithiasis diagnosed between 2012 and 2016.Primary and secondary outcome measuresThe primary outcome of this study was the healthcare utilisation of patients with cholecystolithiasis diagnosed by the GP in terms of referrals to secondary care, laboratory diagnostics, prescribed medication and the prevalence of concomitant abdominal-related diagnoses in a time interval of 3 years before and 3 years after diagnosis of cholecystolithiasis. For secondary outcomes, electronic medical records were studied from seven practices to assess emergency department visits, operation rates and repeat visits for persistent abdominal symptoms. We compared the non-referred group with the referred group.ResultsIn 57% of patients, concomitant abdominal-related diagnoses were recorded besides the diagnosis cholecystolithiasis. In-depth analyses of 294 patients showed a referral rate of 79.3% (n=233); 62.9% (n=185) underwent cholecystectomy. After referral, 55.4% (129/233) returned to the GP for persistent abdominal symptoms. Patients returning after referral were more often treated for another abdominal-related diagnosis before cholecystolithiasis was recorded (51.9% vs 28.8%, p<0.001).ConclusionsThe majority of patients in general practice with gallstones are referred and undergo cholecystectomy. Patients with concomitant abdominal-related diagnoses are likely to return to their physician. GPs should inform patients about these outcomes to improve the shared decision-making process before gallbladder surgery.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Healthcare utilisation of patients with cholecystolithiasis in primary care: a multipractice comparative analysis

et al. 2021

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“…We believe this with such confidence that it remains one of the so-called safe places in general surgery, away from controversy, drama, or questionable expectations. In this issue of JAMA Surgery, Latenstein and colleagues 1 have nicely shown that-of course-it gets complicated.…”

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confidence: 99%

“…When considering an operation to alleviate pain and improve quality of life, it is important that symptoms are incorporated into the surgical decision-making process; this is where the excellent work by Latenstein and colleagues provides the most benefit. Their online tool allows understanding of symptom relief after elective cholecystectomy, which can facilitate shared decision-making with patients, minimizing the chance of performing a procedure with little benefit.…”

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Change to Helping Patients With Symptomatic Cholelithiasis—Does Everybody Win With an Operation?

Collins

Poulose

2021

JAMA Surg

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Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

Comes,

Wennmacker,

Latenstein

et al. 2024

JAMA Surg

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ImportanceThe 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsPatients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.Main Outcomes and MeasuresThe 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.ResultsAmong 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 RelevanceIn 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 RegistrationCCMO Identifier: NTR4022

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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

Cited by 19 publications

References 28 publications

Healthcare utilisation of patients with cholecystolithiasis in primary care: a multipractice comparative analysis

Healthcare utilisation of patients with cholecystolithiasis in primary care: a multipractice comparative analysis

Change to Helping Patients With Symptomatic Cholelithiasis—Does Everybody Win With an Operation?

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

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