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

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ClinicalTrials.gov Identifier: NCT00840138
Recruitment Status : Unknown
Verified February 2009 by Centre of Postgraduate Medical Education.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2009
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
Centre of Postgraduate Medical Education

Study Description
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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.

Condition or disease Intervention/treatment
Cholecystectomy Common Bile Duct Diseases Major Bile Duct Injury Procedure: Surgical reconstruction

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Iatrogenic Common Bile Duct Injuries Following Open Cholecystectomy vs Laparoscopic Cholecystectomy
Study Start Date : January 1996
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Patients with common bile duct injury after open cholecystectomy
 Procedure: Surgical reconstruction

Hepaticojejunostomy

End-to-end anastomosis

Duct suture over T-tube
2
Patients with common bile duct injury after laparoscopic cholecystectomy
 Procedure: Surgical reconstruction

Hepaticojejunostomy

End-to-end anastomosis

Duct suture over T-tube


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated for common bile duct injuries following laparoscopic and open cholecystectomy procedures.
Criteria

Inclusion Criteria:

  • Major common bile duct injury

Exclusion Criteria:

  • Minor common bile duct injury
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ireneusz Kozicki, Medical Centre of Postgraduate Education, Poland
ClinicalTrials.gov Identifier: NCT00840138    
Other Study ID Numbers: Kozicki321
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Bile Duct Diseases
Common Bile Duct Diseases
Wounds and Injuries
Biliary Tract Diseases
Digestive System Diseases