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Completed

NCT Number: NCT04665427

Factors Influencing Occurrence of Bile Leaks in 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.

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Key information

Conditions

Bile Leak Anastomotic Leak Biliary Biliary Fistula Biliary Tract Fistula Digestive System Diseases Digestive System Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oran, 31000, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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,

Other names: hepatico duodenostomy, hepaticojejunostomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative hospital stay

    Time frame: From (day 0) of surgery to (day 90)

    length of postoperative hospital stay

  2. Mortality

    Time frame: From day 0 to day 90

    Mortality after surgery

Sponsors and collaborators

Lead sponsor

University of Oran 1

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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