Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05479227 |
| Other study ID # |
AR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
June 5, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
North Estonia Medical Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
