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*, Robin D. Blok, Oren Lapid, Roel Hompes, Wilhelmus A. Bemelman, Victor P. Alberts, Bas Lamme, Jan H. Wijsman, Jurriaan B. Tuynman, Arend G. J. Aalbers, Geerard L. Beets, Hans F. J. Fabry, Ivan M. Cherepanin, Fatih Polat, Jacobus W. A. Burger, Harm J. T. Rutten, Robert J. Bosker, Koen Talsma, Joost Rothbarth, Cees VerhoefAnthony W. H. van de Ven, Jarmila D. W. van der Bilt, Eelco J. R. de Graaf, Pascal G. Doornebosch, Jeroen W. A. Leijtens, Jeroen Heemskerk, Baljit Singh, Sanjay Chaudhri, Michael F. Gerhards, Tom M. Karsten, Johannes H. W. de Wilt, Andre J. A. Bremers, Ronald J. C. L. M. Vuylsteke, Gijsbert Heuff, Anna A. W. van Geloven, Pieter J. Tanis, Gijsbert D. Musters

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Web of Science)

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.

Original languageEnglish
Article number164
Number of pages8
JournalBMC Surgery
Volume20
Issue number1
DOIs
Publication statusPublished - 23 Jul 2020

Keywords

  • Abdominoperineal resection
  • Rectal cancer
  • Primary perineal wound closure
  • Gluteal turnover flap
  • Perineal wound infection and perineal wound healing
  • PELVIC FLOOR
  • THIGH FLAP
  • RECONSTRUCTION
  • REPAIR

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