Bile Leaks After Biliary Surgery

December 10, 2020 updated by: Anisse Tidjane, University of Oran 1

Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient in whom a bilioenteric anastomosis is performed for any etiology.
Patient in whom a bilioenteric anastomosis is performed for any etiology..
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,
Other Names:
  • hepatico duodenostomy
  • hepaticojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
Time Frame: From (day 0) of surgery 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: From (day 0) of surgery to (day 90)
length of postoperative hospital stay
From (day 0) of surgery to (day 90)
Mortality
Time Frame: From day 0 to day 90
Mortality after surgery
From day 0 to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Benali Tabeti, Pr, University Oran1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Anticipated)

November 18, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 29, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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