Introduction
Laparoscopic cholecystectomy (LC) for symptomatic cholecystolithiasis is one of the most performed abdominal surgeries worldwide, with 700,000 procedures performed in the United States of America annually. (1) However, postoperative outcomes are often mediocre, with 20-40% of patients experiencing persistent pain. (2-3) This is primarily due to the absence of selection criteria for surgery. Internationally, the ROME III criteria are used; however, they are developed as a diagnostic measure for symptomatic cholecystolithiasis rather than a tool to predict surgical outcomes. (4) A randomized trial comparing usual care with a restrictive, criteria-based strategy, utilizing the ROME III criteria, showed that abdominal pain persists in 40% of patients regardless of the study arm. (5) That the ROME criteria are insufficient to predict a pain-free state is at least partly attributable to the sole focus on pain characteristics with inattention to accompanying functional gastrointestinal disease (FGID). Coexistence of FGID is important to consider, as a recent trial showed that 30% of patients with symptomatic cholecystolithiasis meet the criteria for FGID, which is associated with a 2.5-fold increased risk of persistent pain post-cholecystectomy. (6) The poor outcome of LC, accompanying FGID, and the limited predictive value of the ROME criteria to reach a pain-free state, underline the need to develop a tool that aids the surgeon and gastroenterologist in deciding if a patient will benefit from surgery. (7) Therefore, this study presents the development and validation of a clinical decision tool to predict short- and long-term surgical outcomes and to select patients for cholecystectomy.
Aims & Methods
This study evaluates five-year follow-up data of 2 multicentre prospective trials. These studies included a total of 1561 patients diagnosed with symptomatic cholecystolithiasis in 25 hospitals. The primary aim was to develop a predictive model to predict clinically relevant pain reduction five years after cholecystectomy. The model development process included multivariable regression analysis, internal and external validation. Model performance on external validation was assessed through flexible calibration plots, C statistic and decision curve analysis. The TRIPOD guideline were followed.
Results
A total of 1240 of 1561 patients (79.4%) had undergone cholecystectomy at five-year follow-up. After surgery, 746 of 1240 patients (70.2%) reported a clinically relevant pain reduction. A multivariable model showed that male sex, increased VAS pain score at baseline, pain radiating to the back, nausea, and absence of obstipation, diarrhoea and postprandial bloating were independent predictors of clinical pain reduction after cholecystectomy. External validation indicated a good discrimination and calibration between patients with and without clinically relevant pain reduction (C statistic of 0.75; 95% CI, 0.70-0.79).
Conclusion
We developed and validated a model to predict the long-term clinical pain reduction following LC in patients with abdominal pain and gallstones. By adapting the SUCCESS criteria to predict the outcome of surgery, we can enhance the shared decision-making process, allow more tailored care to patients with FGID, reduce ineffective operations, and improve surgical outcomes. Based on our results we advocate for utilizing the ROME III criteria for diagnosing symptomatic cholecystolithiasis, while adopting the SUCCESS criteria for selecting patients for treatment.
References
1. Lammert F, et al. Gallstones. Nat Rev Dis Primers 2016; 2:16024.
2. Wennmacker S, et al. Consistency of patient-reported outcomes after cholecystectomy and their implications on current surgical practice: a prospective multicenter cohort study. Surg Endosc 2017; 31: 215–24.
3. Thistle JL, et al. Factors that predict relief from upper abdominal pain after cholecystectomy. Clin Gastroenterol Hepatol 2011; 9: 891–96.
4. Thunnissen FM, et al. Patients with Clinically Suspected Gallstone Disease: A More Selective Ultrasound May Improve Treatment Related Outcomes. J Clin Med. 2023 Jun 20;12(12):4162.
5. van Dijk AH, 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(10188):2322-2330.
6. de Jong JJ, et al. 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). Ann Surg. 2022 Jun 1;275(6):e766-e772.
7. Latenstein CSS, et al. SECURE trial collaborators. 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. JAMA Surg. 2021 Oct 1;156(10):e213706.
Disclosure
There is no conflict of interes