Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study

Completed

• Conditions: Bile Duct Injury
• Interventions: Procedure: Management of bile duct injury

• Registration Number: NCT05479227
• Lead Sponsor: North Estonia Medical Centre

Brief Summary

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Detailed Description

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.

Background Data: Iatrogenic bile duct injuries (BDI) following laparoscopic cholecystectomy (LC) result in major morbidity and incidental mortality. There is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of BDI. We hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the BDI incidence will decrease over the study period and compare favourably with contemporary literature.

After IRB approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. BDIs were classified according to the Strasberg classification. We hypothesized that due to improved imaging capabilities and collective laparoscopic experience the BDI incidence will decrease over the study period and compare favourably to contemporary literature.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-05
• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• all patients with BDI during laparoscopic cholecystectomy (LC)

Exclusion Criteria

• The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bile duct injuries during laparoscopic cholecystectomy	Management of bile duct injury	The data concerning 241 patients´ BDI emergence, severity, management, and outcomes was analyzed

Primary Outcome Measures

Name	Time	Method
incidence of bile duct injuries	During the years 2008-2018	We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia.

Trial Locations

Locations (1)

Arvo Reinsoo; 🇪🇪 Tallin, Estonia