ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS)

NCT06481007 | Not Yet Recruiting DMC

• 1 other identifier: Univ-2024-0017
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cholecystectomy; Adults; Gall Stone; Polyps; Pancreatitis Biliary; Gallbladder Dyskinesia; Cholecystitis

Keywords

Algeria; Cholecystectomy; mortality; morbidity; 30 days; determinants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Cholecystectomy

patient opérated ( cholecystectomy) and responding to inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oran 1: lead

MeSH Terms

Conditions

Gallstones; Polyps; Biliary Dyskinesia; Cholecystitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases

Central Study Contacts

Anisse Tidjane, Pr

CONTACT

00213 561806152; tidjane.anisse@univ-oran1.dz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 2, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share