- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582240
Bile Duct Injury Digestif
December 1, 2020 updated by: Vania Myralda Giamour Marbun, Dr Cipto Mangunkusumo General Hospital
Full Data BDI Digestif RSCM
Data accumulated from medical record collected from January 2008 until December 2018
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
24
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients who experienced complication after performed cholecystectomy, open or laparoscopy, related to biliary duct
Description
Inclusion Criteria:
- adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Time Frame: january 2008 until december 2018
|
Mortality Rate of Patients Performed Reconstructive Surgery for the Management of Bile Duct Injury Post-Cholecystectomy
|
january 2008 until december 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Time Frame: january 2008 until december 2018
|
Most Frequent Anatomical Location of Bile Duct Injury Post-Cholecystectomy
|
january 2008 until december 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2008
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
December 31, 2018
Study Registration Dates
First Submitted
October 3, 2020
First Submitted That Met QC Criteria
October 3, 2020
First Posted (ACTUAL)
October 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 3, 2020
Last Update Submitted That Met QC Criteria
December 1, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDITJML
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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