Bile Leaks After Biliary Surgery

Sponsor

University of Oran 1 (Other)

Overall Status

Recruiting

CT.gov ID

NCT04665427

Collaborator

(none)

Enrollment

Location

Arm

13.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bile Leak Anastomotic Leak Biliary Biliary Tract Fistula	Other: bilioenteric anastomosis i	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Nov 18, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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..	Other: 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, Other Names: hepatico duodenostomy hepaticojejunostomy

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..

Other: 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,

Other Names:

hepatico duodenostomy

hepaticojejunostomy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative hospital stay [From (day 0) of surgery to (day 90)]
length of postoperative hospital stay
Mortality [From day 0 to day 90]
Mortality after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.