Status:
COMPLETED
APEMESH II - Perineal Reconstruction
Lead Sponsor:
University of Oulu
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-contro...
Detailed Description
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musc...
Eligibility Criteria
Inclusion
- Curative intent abdominoperineal resection and permanent colostomy
Exclusion
- Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
- Immunosupression (cortisone \>10mg/day) or severe malnutrition (BMI \<20)
- Diabetes with 1 or more organ damage
- Dialysis treatment
- Hepatic cirrhosis Child-Bugh B-C
- Potentially curable resection not possible
- Patient undergoing emergency procedures
- Metastatic disease
- Vaginal resection, pelvic exenteration and sacrum resection
- Vaginal perforation
- Pelvic abscess or perforated tumor
- Pregnant or suspected pregnancy
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04779125
Start Date
March 19 2021
End Date
March 1 2022
Last Update
February 1 2024
Active Locations (1)
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1
Oulu University Hospital
Oulu, Finland