CClinicalTrials.gg
CompletedNCT05479227Updated Jul 29, 2022

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

An observational study in Bile Duct Injury, sponsored by North Estonia Medical Centre. Completed at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by North Estonia Medical Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
241
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bile Duct Injury

Browse trials for

03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 241 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

North Estonia Medical Centre is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population consists of patients who experienced a bile duct injury during laparoscopic cholecystectomy during 2008-2018 in Estonian national health care facilities. The data was obtained according to coding in National Health Insurance Fund electronic database. Data on readmissions related to BDIs and their subsequent complications were collected from the National Institute for Health Development repository.

Inclusion criteria

  • all patients with BDI during laparoscopic cholecystectomy (LC)

Exclusion criteria

Exclusion Criteria:

  • The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
241 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with bile duct injuries during laparoscopic cholecystectomy

    The data concerning 241 patients´ BDI emergence, severity, management, and outcomes was analyzed

    Procedure: Management of bile duct injury

Interventions

  • ProcedureManagement of bile duct injury

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

06

What researchers measure

Primary outcomes

  1. incidence of bile duct injuries

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

    Time frame: During the years 2008-2018

07

Study locations

1 site
  • Arvo Reinsoo
    Tallin, Estonia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05479227
Lead sponsor
North Estonia Medical Centre
Collaborators
University of Tartu
Responsible party
Arvo Reinsoo (Principal investigator, general surgeon, MD, North Estonia Medical Centre) — Principal investigator
First posted
Jul 29, 2022
Start date
Jun 1, 2019
Primary completion
Jun 1, 2021
Completion
Jun 5, 2022
Last update
Jul 29, 2022

Study contacts

Arvo Reinsoo, MD
principal investigator · North Estonia Medical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion