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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
January 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2019
CompletedOctober 22, 2019
October 1, 2019
3.7 years
January 15, 2016
October 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to complete the biliodigestive anastomosis
30 minutes
Study Arms (2)
Continuous suture technique
EXPERIMENTALThe BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
Interrupted suture technique
ACTIVE COMPARATORThe BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
Interventions
The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
Eligibility Criteria
You may qualify if:
- Patients over 18 years of age
- Scheduled for elective BDA procedure
- Primary BDA procedure
- Diameter of DHC \> 7mm
- Written consent
You may not qualify if:
- Previous BDA procedure
- Impaired mental state or language problems
- Lacking compliance
- Emergency procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Dresden, Germany
Related Publications (1)
Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN, Kahlert C, Distler M, Weitz J, Reissfelder C. Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial. BJS Open. 2023 Jan 6;7(1):zrac163. doi: 10.1093/bjsopen/zrac163.
PMID: 36723996DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Reißfelder, MD
christoph.reissfelder@uniklinikum-dresden.de
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2016
First Posted
January 20, 2016
Study Start
January 20, 2016
Primary Completion
September 17, 2019
Study Completion
September 17, 2019
Last Updated
October 22, 2019
Record last verified: 2019-10