BIOPEX 2
Research type
Research Study
Full title
Gluteal Turnover Flap For Closure of the Perineal Wound after Abdominoperineal Resection for Rectal Cancer
IRAS ID
277324
Contact name
H.J. Bonjer
Contact email
Sponsor organisation
Amsterdam UMC, location AMC
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
Abdominoperineal resection (APR) is indicated for patients with a low rectal cancer and involves removal of the back passage and a permanent stoma ie bag. How the back passage wound is closed is controversial with several techniques currently being employed. Primary perineal wound closure is still the standard of care in most countries. In a previous trial this research group had shown that biological mesh closure did not improve wound healing (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose and with the advantage of not having a donor site scar ie no additional scars. The aim of this study is to investigate whether a gluteal turnover flap improves perineal wound healing after APR for rectal cancer compared to simple closure of the defect.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0097
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion