Abstract
BackgroundAbdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (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. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer.MethodsPatients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function.DiscussionThe uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place.Trial registrationThe trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.
Highlights
Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique
The objective of this study is to investigate the effect of gluteal turnover flap closure of the perineal wound with primary closure of the perineal wound after APR for rectal cancer
A variety of techniques have been described for closure of the perineal defect following APR for rectal cancer
Summary
Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. The high rate of perineal morbidity after primary wound closure has resulted in a continuous discussion on alternative closure methods for the perineal wound after APR. Biological mesh closure has been investigated in our previous randomised controlled trial (BIOPEX-study), and showed no superiority in perineal wound healing compared to primary closure. The absence of improvement in perineal wound healing after biological mesh closure is probably related to the formation of a dead space between the mesh and the perineal skin after APR. This dead space is prone to fluid accumulation, which can subsequently get infected with abscess formation
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