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Multicenter Study
. 2025 Aug 1;111(8):5205-5214.
doi: 10.1097/JS9.0000000000002550. Epub 2025 May 29.

Development and validation of a clinical decision tool for predicting long-term pain reduction following laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis: a prospective cohort study

Daan J Comes  1 , Carmen S S Latenstein  1 , Jarmila D W van der Bilt  2 , Sandra C Donkervoort  3 , Joos Heisterkamp  4 , Vincent B Nieuwenhuijs  5 , Jennifer M J Schreinemakers  6 , Hein B A C Stockmann  7 , Bastiaan Wiering  8 , Joost P H Drenth  9 , Cornelis J H M van Laarhoven  1 , Marcel G W Dijkgraaf  10 , Marja A Boermeester  11   12 , Gerjon Hannink  13 , Philip R de Reuver  1 ; SECURE trial collaborators
Affiliations
Multicenter Study

Development and validation of a clinical decision tool for predicting long-term pain reduction following laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis: a prospective cohort study

Daan J Comes et al. Int J Surg. .

Abstract

Background: The applicability of the recently reported predictors to predict pain reduction after laparoscopic cholecystectomy (LC) is limited by only predicting short-term outcomes. The aim of this study was to develop and externally validate a model to predict clinically relevant pain reduction 5 years after LC.

Materials and methods: This study reports on 5-year follow-up data of two multicenter prospective trials in 25 hospitals. Only patients who underwent LC were included. The model was developed using data from the SUCCESS cohort ( n = 494) and externally validated using data from the SECURE trial ( n = 1067). Both studies applied identical inclusion criteria for patients with uncomplicated cholecystolithiasis. The model was developed using multivariable logistic regression and internally validated using bootstrapping and subsequently validated externally. Model performance was evaluated using discrimination, calibration, and decision curve analysis.

Results: A total of 1561 patients were included of which 1240 (79.4%) who had received LC after 5-year follow-up; 746 of 1240 patients (70.2%) reported a clinically relevant pain reduction. A multivariable model showed that male sex, increased Visual Analog Scale pain score at baseline, pain radiating to the back, nausea, with absence of obstipation, diarrhea, and postprandial bloating were independent predictors for long-term clinically relevant pain reduction. External validation indicated good discrimination and calibration between patients with and without clinically relevant pain reduction (C-statistic, 0.75; 95% CI, 0.70-0.79).

Conclusion: In this study, we developed and validated a model for predicting long-term clinically relevant pain reduction after LC. The model may serve as an instrument to improve patient selection for surgery and may enhance shared decision making.

Keywords: gallstone disease; laparoscopic cholecystectomy; long-term outcome; prediction model.

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References

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    1. van Dijk AH, Wennmacker SZ, de Reuver PR, et al. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial. Lancet 2019;393:2322–30.
    1. Latenstein CSS, Wennmacker SZ, de Jong JJ, van Laarhoven C, Drenth JPH, de Reuver PR. Etiologies of long-term postcholecystectomy symptoms: a systematic review. Gastroenterol Res Pract 2019;2019:4278373.
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    1. Latenstein CSS, de Jong JJ, Eppink JJ, et al. Prevalence of dyspepsia in patients with cholecystolithiasis: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2019;31:928–34.

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