Factors Influencing Occurrence of Bile Leaks in Surgery

NCT ID: NCT04665427

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bile Leak Anastomotic Leak Biliary Biliary Tract Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient in whom a bilioenteric anastomosis is performed for any etiology.

Patient in whom a bilioenteric anastomosis is performed for any etiology..

Group Type OTHER

bilioenteric anastomosis i

Intervention Type OTHER

The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bilioenteric anastomosis i

The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hepatico duodenostomy hepaticojejunostomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.

Exclusion Criteria

* Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
* Subjects under the age of 18. Years.
* Subjects who refused to participate in this study.
* Cases of biliary and pancreatic anastomoses performed during the same surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oran 1

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anisse Tidjane

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benali Tabeti, Pr

Role: STUDY_CHAIR

University Oran1

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.

Oran, , Algeria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Algeria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UOran1_surgery_Bile_leak

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Complications of Cholecystostomy in ACC
NCT06227936 NOT_YET_RECRUITING