ALgerian Cholecystectomy Outcomes and Determinants Study... | NCT06481007

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

NCT06481007

Sponsor

University of Oran 1

Status

Unknown status

Last Update Posted

Jul 1, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cholecystectomy
Adults
Gall Stone
Polyps
Pancreatitis Biliary
Gallbladder Dyskinesia
Cholecystitis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Estimated

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Jul 2, 2025Estimated

First Submitted Date

Jun 22, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jul 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cholecystectomy		patient opérated ( cholecystectomy) and responding to inclusion criteria

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anisse Tidjane, Pr	Contact	00213 561806152		tidjane.anisse@univ-oran1.dz

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

we are not going to share data , but the study will be published in an open acces journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones
D011127	Polyps
D001657	Biliary Dyskinesia
D002764	Cholecystitis

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided