A new model could help surgeons predict the probability of pain reduction following cholecystectomy and inform decisions regarding which patients with uncomplicated cholelithiasis could benefit from surgery. The model was developed and validated in a study published in JAMA Surgery.
Data from 2 multicenter, prospective trials in the Netherlands were used. Patients with symptomatic uncomplicated cholelithiasis, defined as gallstone disease without signs of complicated cholelithiasis, were included. Patient characteristics, comorbidities, surgical outcomes, pain, and symptoms were assessed at baseline and at 6 months follow-up. Researchers then developed a multivariable regression model to predict a pain-free state or a clinically relevant reductions in pain post-surgery.
Overall, 1561 patients were included, 494 of which were placed in the development cohort and 1067 in the validation cohort. The mean age of patients in the development cohort was 51.6 (SD, 14.5) years. At baseline, the median pain scores in the development cohort were 35.8 (interquartile range [IQR], 28.4-43.1) for Izbicki pain scores and 8.0 (IQR, 6.5-9.5) using the visual analog scale (VAS) score.
Among patients in the development cohort, 395 (80.0%) underwent cholecystectomy, of which 225 (57.0%) reported a pain-free state and 295 (74.7%) reported a clinically relevant reduction in pain.
The model to predict a pain-free state found a higher chance of being pain-free after cholecystectomy for patients who were of more advanced age, had no history of abdominal surgery, low VAS baseline scores, reported pain during attacks, didn’t use pain medication, and did not report having heartburn. Independent predictors of clinically relevant pain reduction were more advanced age, no history of abdominal surgery, high VAS baseline scores, pain radiation to the back, a positive pain response to simple analgesics, nausea during pain attacks, and no heartburn.
Internal validation of the model found very good discrimination between patients with and without clinically relevant reductions of pain (concordance [C] statistic, 0.80; 95% CI, 0.74-0.84). After external validation, the C statistic was 0.74 (95% CI, 0.70-0.78) and the model showed good discrimination between patients with and without clinically relevant pain reduction as well as fair calibration with some overestimation of probability.
The study was limited by the number of predictors included in the analysis due to the sample size. Additionally, the wide confidence intervals limit the model’s clinical utility.
Researchers concluded, “Despite this considerable uncertainty, this information about prognostic certainty and uncertainty may still support transparent shared decision-making between patient and physician, as it is the best evidence currently available to our knowledge.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Latenstein CSS, Hannink G, van der Bilt JDW, et al. 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. Published online October 13, 2021. doi: 10.1001/jamasurg.2021.3706