Factors Influencing Occurrence of Bile Leaks in Surgery

NCT04665427 | Completed DMC

• 1 other identifier: UOran1_surgery_Bile_leak
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bile Leak; Anastomotic Leak Biliary; Biliary Tract Fistula

Keywords

hepatobiliary surgery; Morbidity; leak; anastomosis

Outcome Measures

Primary Outcomes (1)

• The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).

  Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.

  From (day 0) of surgery to (day 90)

Secondary Outcomes (2)

• Postoperative hospital stay

  From (day 0) of surgery to (day 90)

• Mortality

  From day 0 to day 90

Study Arms (1)

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

OTHER

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

Other: bilioenteric anastomosis i

Interventions

bilioenteric anastomosis i 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,

Also known as: hepatico duodenostomy, hepaticojejunostomy

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oran 1: lead

Study Sites (1)

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

Oran, 31000, Algeria

Location

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Benali Tabeti, Pr

  University Oran1

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 11, 2020
• Study Start: November 18, 2020
• Primary Completion: July 18, 2022
• Study Completion: August 1, 2022
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AL (1)