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Clinical Trials/NCT02658643
NCT02658643
Completed
Not Applicable

Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique

Technische Universität Dresden1 site in 1 country80 target enrollmentJanuary 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Continuous or Interrupted Suture
Sponsor
Technische Universität Dresden
Enrollment
80
Locations
1
Primary Endpoint
Time to complete the biliodigestive anastomosis
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.

Detailed Description

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.

Registry
clinicaltrials.gov
Start Date
January 20, 2016
End Date
September 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients over 18 years of age
  • Scheduled for elective BDA procedure
  • Primary BDA procedure
  • Diameter of DHC \> 7mm
  • Written consent

Exclusion Criteria

  • Previous BDA procedure
  • Impaired mental state or language problems
  • Lacking compliance
  • Emergency procedure

Outcomes

Primary Outcomes

Time to complete the biliodigestive anastomosis

Time Frame: 30 minutes

Study Sites (1)

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