NCT00840138

Brief Summary

In this prospective study the investigators compared common bile duct injuries (CBDI) following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35 patients in each group. To date, no detailed study concerning this matter has been published. LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD, they were located closer to the liver hilus, and they were more extended.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 1996

Longer than P75 for all trials

Status
unknown

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, 1996

Completed
13.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

16.9 years

First QC Date

February 9, 2009

Last Update Submit

February 9, 2009

Conditions

CholecystectomyCommon Bile Duct DiseasesMajor Bile Duct Injury

Study Arms (2)

1

Patients with common bile duct injury after open cholecystectomy

Procedure: Surgical reconstruction

2

Patients with common bile duct injury after laparoscopic cholecystectomy

Procedure: Surgical reconstruction

Interventions

Surgical reconstructionPROCEDURE

Hepaticojejunostomy End-to-end anastomosis Duct suture over T-tube

12

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for common bile duct injuries following laparoscopic and open cholecystectomy procedures.

You may qualify if:

  • Major common bile duct injury

You may not qualify if:

  • Minor common bile duct injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Common Bile Duct Diseases

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

January 1, 1996

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 10, 2009

Record last verified: 2009-02