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Completed

NCT Number: NCT05479227

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arvo Reinsoo

Tallinn, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Management of bile duct injury

Procedure

There are different options for BDI management, we analyzed their utilization and results

Primary outcomes

  1. incidence of bile duct injuries

    Time frame: During the years 2008-2018

    We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia.

Sponsors and collaborators

Lead sponsor

North Estonia Medical Centre

Other

Collaborators

  • University of Tartu

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

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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