Mucosal Flap Reinforced Colorectal Anastomosis and Trans-Anal Vacuum Drainage: A Feasibility Study
NCT04735107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-02-02
Summary
Background: Dehiscence of colorectal anastomosis is a serious complication associated with increased mortality and impaired functional and oncological outcomes. We hypothesised that anastomosis reinforcement and vacuum trans-anal drainage could eliminate some risk factors of colorectal anastomotic dehiscence,including mechanically stapled anastomosis instability and local infection.
Conditions
Interventions
- PROCEDURE
-
colorectal anastomosis reinforcement and trans-anal drainage
Circular mucosal flap created to cover stapled anastomosis + vacuum sponge drainage
Sponsors & Collaborators
-
University Hospital, Martin
collaborator OTHER -
Comenius University
lead OTHER
Principal Investigators
-
Alexander Ferko, Prof.MD,PhD · Comenius University, Jessenius Medical Faculty in Martin
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2021-05-01
- Completion
- 2021-09-01
Countries
- Slovakia
Study Locations
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