ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS) (AL-CODS)

Algerian Cholecystectomy Outcomes and Determinants Study

Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. While generally considered safe, this surgery can be associated with significant morbidity and mortality, particularly in certain populations or healthcare settings. Understanding these outcomes and the factors influencing them is crucial for improving patient care and surgical practices.

In Algeria, the healthcare landscape presents unique challenges and opportunities for evaluating surgical outcomes. Limited studies have specifically focused on the morbidity and mortality associated with cholecystectomy in this context. This study aims to fill that gap by providing comprehensive data on 30-day postoperative outcomes following cholecystectomy for benign gallbladder diseases in Algeria. Such data is essential for benchmarking current practices, identifying areas for improvement, and ultimately enhancing patient safety and surgical efficacy.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis; Polyps; Cholecystectomy; Adults; Gall Stone; Gallbladder Dyskinesia; Pancreatitis Biliary

Detailed Description

This study seeks to bridge this knowledge gap by offering detailed data on 30-day postoperative outcomes after cholecystectomy for benign gallbladder diseases in Algeria. This information is crucial for benchmarking existing practices, pinpointing areas for enhancement, and ultimately improving patient safety and surgical effectiveness.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Anisse Tidjane, Pr; Phone Number: 00213 561806152; Email: tidjane.anisse@univ-oran1.dz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients aged 18 years and older who undergo cholecystectomy for benign gallbladder diseases in Algeria. This includes patients who have their gallbladders removed due to conditions such as gallstones, cholecystitis, biliary dyskinesia and any other benign pathology

Description

Inclusion Criteria:

• Patients aged 18 years and older.
• Undergoing cholecystectomy.
• Surgery performed in public or private hospitals in Algeria.
• Surgery performed from January 1, 2025, to June 30, 2025.

Exclusion Criteria:

• Patients younger than 18 years.
• Patients refusing to participate.
• Cholecystectomy performed for Gallbladder cancer.
• Cholecystectomy performed outside the inclusion period.
• Cholecystectomies performed in conjunction with other major surgeries.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cholecystectomy; patient opérated ( cholecystectomy) and responding to inclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the 30-day mortality and morbidity	Evaluation of rate of mortality and morbidity at 30 day	occuring in of before 30 day postopérative période.
factors associated with 30-day morbidity and mortality	determinants of the occurence of complications and mortality on or before 30 day in postopérative period	occuring in of before 30 day postopérative période.

Secondary Outcome Measures

Outcome Measure	Time Frame
estimate the incidence of incidental gallbladder cancer discovered during cholecystectomy in Algeria.	postoperative periode ( during or after surgical procedure)
estimate the incidence of bile duct injuries following cholecystectomy for benign diseases	occuring in of before 30 day postopérative periode.
assess surgical practices related to cholecystectomy in Algeria.	During surgical procedure ( Cholecystectomy)

Collaborators and Investigators

• Sponsor: University of Oran 1

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 2, 2025

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: mortality; Cholecystectomy; morbidity; 30 days; determinants; Algeria
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Cholecystitis; Dyskinesias; Pancreatitis; Gallstones; Biliary Dyskinesia
• Other Study ID Numbers: Univ-2024-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we are not going to share data , but the study will be published in an open acces journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No