NCT05479227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 26, 2022

Last Update Submit

July 28, 2022

Conditions

Bile Duct Injury

Outcome Measures

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.

    During the years 2008-2018

Study Arms (1)

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

Management of bile duct injuryPROCEDURE

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

Patients with bile duct injuries during laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • all patients with BDI during laparoscopic cholecystectomy (LC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arvo Reinsoo

Tallinn, Estonia

Location

Study Officials

  • Arvo Reinsoo, MD

    North Estonia Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, general surgeon, MD

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 29, 2022

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 5, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations

ES(1)