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. 2020 Jul 23;20(1):164.
doi: 10.1186/s12893-020-00823-7.

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)

Sarah Sharabiany  1 , Robin D Blok  2   3 , Oren Lapid  4 , Roel Hompes  2 , Wilhelmus A Bemelman  2 , Victor P Alberts  2 , Bas Lamme  5 , Jan H Wijsman  6 , Jurriaan B Tuynman  7 , Arend G J Aalbers  8 , Geerard L Beets  8 , Hans F J Fabry  9 , Ivan M Cherepanin  9 , Fatih Polat  10 , Jacobus W A Burger  11 , Harm J T Rutten  11   12 , Robert J I Bosker  13 , Koen Talsma  13 , Joost Rothbarth  14 , Cees Verhoef  14 , Anthony W H van de Ven  15 , Jarmila D W van der Bilt  15 , Eelco J R de Graaf  16 , Pascal G Doornebosch  16 , Jeroen W A Leijtens  17 , Jeroen Heemskerk  17 , Baljit Singh  18 , Sanjay Chaudhri  18 , Michael F Gerhards  19 , Tom M Karsten  19 , Johannes H W de Wilt  20 , Andre J A Bremers  20 , Ronald J C L M Vuylsteke  21 , Gijsbert Heuff  21 , Anna A W van Geloven  22 , Pieter J Tanis  2 , Gijsbert D Musters  2
Affiliations

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)

Sarah Sharabiany et al. BMC Surg. .

Abstract

Background: Abdominoperineal 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.

Methods: Patients 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.

Discussion: The 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 registration: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Keywords: Abdominoperineal resection; Gluteal turnover flap; Perineal wound infection and perineal wound healing; Primary perineal wound closure; Rectal cancer.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow-diagram: study design
See this image and copyright information in PMC

References

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