APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
1 other identifier
observational
30
1 country
1
Brief Summary
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
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
April 1, 2020
CompletedStudy Start
First participant enrolled
April 3, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFebruary 1, 2024
January 1, 2024
11 months
April 1, 2020
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Comprehensive Complication index
Comprehensive Complication index is used to evaluate outcome
30 days
Secondary Outcomes (8)
Surgical site infection
30 days
Reoperation rate
30 days
Operative time
30 days
Length of stay
30 days
Costs
30 days
- +3 more secondary outcomes
Study Arms (1)
Mesh group
After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.
Interventions
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
Eligibility Criteria
All study patients who have abdominoperineal resection
You may qualify if:
- Abdominoperineal resection and permanent colostoma
You may not qualify if:
- Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
- Potentially curable resection not possible
- Patient undergoing emergency procedure
- Metastatic disease
- Pregnant or suspected pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elisa Mäkäräinenlead
Study Sites (1)
Oulu University Hospital
Oulu, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisa Mäkäräinen-Uhlbäck, M.D.
Oulu University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 6, 2020
Study Start
April 3, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2022
Last Updated
February 1, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share