Clinical trial NCT06481007: ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS)
Official title: Algerian Cholecystectomy Outcomes and Determinants Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholecystectomy
Adults
Gall Stone
Polyps
Pancreatitis Biliary
Gallbladder Dyskinesia
Cholecystitis
Keywords: Algeria
Cholecystectomy
mortality
morbidity
30 days
determinants
Lead sponsor: University of Oran 1
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the 30-day mortality and morbidity
timeFrame: occuring in of before 30 day postopérative période.
measure: factors associated with 30-day morbidity and mortality
timeFrame: occuring in of before 30 day postopérative période.
Secondary outcomes:
measure: estimate the incidence of incidental gallbladder cancer discovered during cholecystectomy in Algeria.
timeFrame: postoperative periode ( during or after surgical procedure)
measure: estimate the incidence of bile duct injuries following cholecystectomy for benign diseases
timeFrame: occuring in of before 30 day postopérative periode.
measure: assess surgical practices related to cholecystectomy in Algeria.
timeFrame: During surgical procedure ( Cholecystectomy)
Other outcomes:
Locations:
Study officials:
References: