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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Centre of Postgraduate Medical Education.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier:
NCT00840138
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose
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 Intervention
Cholecystectomy Common Bile Duct Diseases Major Bile Duct Injury Procedure: Surgical reconstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Iatrogenic Common Bile Duct Injuries Following Open Cholecystectomy vs Laparoscopic Cholecystectomy

Further study details as provided by Centre of Postgraduate Medical Education:

Enrollment: 70
Study Start Date: January 1996
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Ireneusz Kozicki, Medical Centre of Postgraduate Education, Poland
ClinicalTrials.gov Identifier: NCT00840138     History of Changes
Other Study ID Numbers: Kozicki321
Study First Received: February 9, 2009
Last Updated: February 9, 2009

Additional relevant MeSH terms:
Wounds and Injuries
Bile Duct Diseases
Common Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 23, 2017