Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Jun 2023
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJune 7, 2023
June 1, 2023
7 months
October 26, 2021
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Analysis of efficacy of repair in laparoscopic and open surgical management of post cholecystectomy bile duct injury
Baseline
Study Arms (2)
laparoscopic management of post cholecystectomy bile duct injury.
Under general intubation anaesthesia, trocars are inserted in the abdomen, insufflation by CO2 adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram then according to the site and the size of the injury repair will done. If the injury is small simple repair or repair on T-tube will be done. If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done. Intra-abdominal drains insertion
open surgical management of post cholecystectomy bile duct injury.
Under general intubation anaesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram according to the site and the size of the injury repair will be done. If the injury is small simple repair or repair on T-tube will be done . If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done .Intra-abdominal drains insertion.
Interventions
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Eligibility Criteria
patients with bile duct injury post cholecystectomy
You may qualify if:
- All patients with post cholecystectomy bile duct injuries admitted to surgery department in Asyut University Hospitals and El-Rajhi hospital at the period of the study.
- Patients fit for surgery.
- Patients informed consent for study.
- Patients with signs and symptoms due to Bile duct injury like abdominal pain, jaundice and high liver function parameters
You may not qualify if:
- Unfit cases for laparoscopic surgery.
- Unfit patients for open surgery.
- Patients refuse consent to participate in the study.
- Patients who had previous repair.
- Patients who present with abdominal sepsis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Surgery Resident: Amir William Samir Fahmy
Study Record Dates
First Submitted
October 26, 2021
First Posted
February 17, 2022
Study Start
June 1, 2023
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
June 7, 2023
Record last verified: 2023-06