A Comparison of Bile Duct Injuries Following Open Cholecystectomy Versus Laparoscopic Cholecystectomy

February 9, 2009 updated by: Centre of Postgraduate Medical Education

Comparison of Iatrogenic Common Bile Duct Injuries Following Open Cholecystectomy vs Laparoscopic Cholecystectomy

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

70

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

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Major common bile duct injury

Exclusion Criteria:

  • Minor common bile duct injury

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients with common bile duct injury after open cholecystectomy

Hepaticojejunostomy

End-to-end anastomosis

Duct suture over T-tube

2
Patients with common bile duct injury after laparoscopic cholecystectomy

Hepaticojejunostomy

End-to-end anastomosis

Duct suture over T-tube

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

January 1, 1996

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

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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