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NCT00840138 Clinical Trial

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

Cholecystectomy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00840138
Other study ID # Kozicki321
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 9, 2009
Last updated February 9, 2009
Start date January 1996
Est. completion date December 2012

Study information
Verified date February 2009
Source Medical Centre of Postgraduate Education, Poland
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria:

- Major common bile duct injury

Exclusion Criteria:

- Minor common bile duct injury

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical reconstruction
Hepaticojejunostomy End-to-end anastomosis Duct suture over T-tube

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical Centre of Postgraduate Education, Poland
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