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Analysis of Biliodigestive Anastomosis Techniques (BDA)

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ClinicalTrials.gov Identifier: NCT02658643
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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.

Condition or disease Intervention/treatment Phase
Continuous or Interrupted Suture Procedure: Continuous suture technique Procedure: Interrupted suture technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique
Actual Study Start Date : January 20, 2016
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019

Arm Intervention/treatment
Experimental: 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: 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

Active Comparator: 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
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




Primary Outcome Measures :
  1. Time to complete the biliodigestive anastomosis [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658643


Locations
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Germany
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Dresden, Germany
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Christoph Reißfelder, MD christoph.reissfelder@uniklinikum-dresden.de
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02658643    
Other Study ID Numbers: VTG-06
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Keywords provided by Technische Universität Dresden:
biliodigestive anastomosis techniques