NCT04582240

Brief Summary

Data accumulated from medical record collected from January 2008 until December 2018

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

11 years

First QC Date

October 3, 2020

Last Update Submit

December 1, 2020

Conditions

SurgeryBiliary DiseaseBile Duct InjurySepsisJaundice, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia

    Mortality Rate of Patients Performed Reconstructive Surgery for the Management of Bile Duct Injury Post-Cholecystectomy

    january 2008 until december 2018

Secondary Outcomes (1)

  • Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia

    january 2008 until december 2018

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who experienced complication after performed cholecystectomy, open or laparoscopy, related to biliary duct

You may qualify if:

  • adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gallbladder DiseasesSepsisJaundice, Obstructive

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsJaundiceHyperbilirubinemiaSkin ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff of Digestive Division - General Surgery Department

Study Record Dates

First Submitted

October 3, 2020

First Posted

October 9, 2020

Study Start

January 1, 2008

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

December 3, 2020

Record last verified: 2020-12