ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS): Protocol for a prospective multicentre observational study

Abstract

Introduction: Cholecystectomy is common, yet outcomes vary with case‑mix, technique, and system capacity. Algeria lacks contemporary national data. The AL‑CODS study will estimate 30‑day outcomes after cholecystectomy and identify determinants relevant to the Algerian context.

Methods: AL‑CODS is a prospective, multicentre observational cohort across public and private hospitals in Algeria (1 January–30 June 2025). Consecutive adults undergoing cholecystectomy for presumed benign disease will be enrolled via a secure electronic case report form. Primary outcomes are 30‑day morbidity (Clavien-Dindo) and all‑cause mortality. Secondary outcomes include bile duct injury (Strasberg classification), incidental gallbladder cancer on histology, and key practice patterns (operative approach, cholangiography, drains, antibiotics, day‑case surgery, timing, use of extraction devices, length of stay). A minimum sample of 526 cases provides precise estimation of rare events (e.g., bile duct injury ≈0.8%) with ±1% margin of error at 99% confidence. Prespecified analyses will use descriptive statistics and multivariable logistic regression; model building will consider clinical plausibility, multicollinearity, and standard diagnostics, reporting adjusted odds ratios with 95% confidence intervals.

Ethics and governance: Ethical approval has been granted by EHU 1er Novembre 1954 (EHU‑2024‑éthique‑01). Written informed consent is required. Data are stored on a password‑protected platform with investigator‑restricted access. The study is registered at ClinicalTrials.gov (NCT‑64810007) and will follow STROBE guidance.

Expected impact: AL‑CODS will deliver the first national estimates of cholecystectomy outcomes in Algeria, define context‑specific risk factors to inform training and peri‑operative decision‑making, quantify the incidence of bile duct injury and incidental gallbladder cancer, and provide benchmarks for quality improvement. Results will support guideline development and contribute evidence from a lower‑middle‑income setting to the international literature.