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Randomized Controlled Trial
. 2021 Oct 1;156(10):e213706.
doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.

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

Carmen S S Latenstein  1 , Gerjon Hannink  2 , Jarmila D W van der Bilt  3 , Sandra C Donkervoort  4 , Quirijn A J Eijsbouts  5 , Joos Heisterkamp  6 , Vincent B Nieuwenhuijs  7 , Jennifer M J Schreinemakers  8 , Bastiaan Wiering  9 , Marja A Boermeester  10 , Joost P H Drenth  11 , Cornelis J H M van Laarhoven  1 , Marcel G W Dijkgraaf  12 , Philip R de Reuver  1 ; SECURE trial collaborators
Collaborators, Affiliations
Randomized Controlled Trial

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

Carmen S S Latenstein et al. JAMA Surg. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Boermeester reports serving as a speaker and instructor for and receiving grants from Kinetic Concepts Inc and Johnson & Johnson; receiving grants from New Compliance; and serving as a speaker and instructor for Gore, Smith & Nephew, TelaBio, Bard, and GD Medical outside the submitted work. Dr Drenth reports grants from Gilead outside the submitted work, paid to the Radboud University Medical Center. Dr de Reuver reports grants from Dutch Innovation Fund Healthcare Insurers, The Netherlands Organization for Health Research and Development, and Centraal Ziekenhuis Healthcare Insurance during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart of Development and Validation Cohorts
Inclusion criteria for both trials: patients aged 18 to 95 years referred to a surgical outpatient clinic with abdominal pain and ultrasonically confirmed gallstones. ASA indicates American Society of Anesthesiologists; IC, informed consent.
Figure 2.
Figure 2.. Calibration Plot of the Prediction Model for Clinically Relevant Pain Reduction After Internal and External Validation
A, Calibration plot of the prediction model for a clinically relevant pain reduction after internal validation represents the observed proportion vs the predicted probabilities. The broom plot shows the distribution of predicted probabilities for patients with (1) and without (0) clinically relevant pain reduction. B, Calibration plot of the prediction model for a clinically relevant pain reduction after external validation before recalibration of the intercept, which did not result in an improved model, represents the observed proportion vs the predicted probabilities. The broom plot shows the distribution of predicted probabilities for patients with (1) and without (0) clinically relevant pain reduction.
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