Scholarly Article
ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS): Protocol for a prospective multicentre observational study
Tidjane, Anisse, Tidjane, Mohammed, Tabeti, Benali
2025-09-30 · Impact Surgery · Impact Health Publishing Group
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.
Keywords
Cholecystectomy, Complication, Outcomes, Mobidity, Mortality, Bile duct injury, Incidental gallbladder cancer, Surgical outcomes, Low- and middle-income countries
Citation Details
Impact Surgery, No. 12, pp. 199-204