NCT02658643

Analysis of Biliodigestive Anastomosis Techniques (BDA)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Continuous or Interrupted Suture

Interventions

Type	Name	Description
PROCEDURE	Continuous suture technique	The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
PROCEDURE	Interrupted suture technique	The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

Timeline

• Start date: 2016-01-20
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2016-01-20
• Last updated: 2019-10-22

Locations

1 site across 1 country: Germany