Mucosal Flap Reinforced Colorectal Anastomosis and Trans-Anal Vacuum Drainage: A Feasibility Study
Endodrain
Low Anterior Resection Combined With Transanal Reinforcement and Endoluminal Sponge Vacuum Drainage
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration 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
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFebruary 2, 2021
January 1, 2021
2.5 years
January 27, 2021
January 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of anastomotic leak
Leak of colorectal anastomosis proven by endoscopy/or/and computed tomography
30 days
Defunction ileostomy rate
Rate of fecal diversion in group of treated patients
30 days
Secondary Outcomes (1)
Postoperative morbidity
30 days
Study Arms (1)
Reinforcement
EXPERIMENTALLow anterior resection + mucosa flap reinforcement + vacuum sponge endoluminal drainage
Interventions
Circular mucosal flap created to cover stapled anastomosis + vacuum sponge drainage
Eligibility Criteria
You may qualify if:
- Patients with diagnosed extraperitoneal rectal cancer, cT1-cT4
- Patient with low anterior resection and double-stapled anastomosis technique
You may not qualify if:
- Patients not provided written informed consent
- Patients with cT4: with pelvic side wall involement, requiring pelvic more extensive procedure
- Patients with recurrent rectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Comenius Universitylead
- University Hospital, Martincollaborator
Study Sites (1)
University Hospital Martin
Martin, Slovakia
Related Publications (1)
Ferko A, Vana J, Adamik M, Svec A, Zacek M, Demeter M, Grendar M. Mucosa plication reinforced colorectal anastomosis and trans-anal vacuum drainage: a pilot study with preliminary results. Updates Surg. 2021 Dec;73(6):2145-2154. doi: 10.1007/s13304-021-01105-4. Epub 2021 Jun 5.
PMID: 34089500DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Ferko, Prof.MD,PhD
Comenius University, Jessenius Medical Faculty in Martin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 2, 2021
Study Start
November 1, 2018
Primary Completion
May 1, 2021
Study Completion
September 1, 2021
Last Updated
February 2, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share