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