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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735107 on ClinicalTrials.gov