- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665427
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
Status
Unknown
Intervention / Treatment
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
- Name: Anisse Tidjane, Dr
- Phone Number: 0561806152
- Email: tidjane.anisse@univ-oran1.dz
Study Locations
-
-
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Oran, Algeria, 31000
- Recruiting
- Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.
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Contact:
- Anisse Tidjane, MCA
- Phone Number: 00213561806152
- Email: tidjane.anisse@univ-oran1.dz
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Contact:
- Amel Laredj, Dr
- Email: ameldj81@yahoo.fr
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-
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:
|
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)
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOran1_surgery_Bile_leak
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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