TY - JOUR
T1 - Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer
T2 - study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)
AU - Sharabiany, Sarah
AU - Blok, Robin D.
AU - Lapid, Oren
AU - Hompes, Roel
AU - Bemelman, Wilhelmus A.
AU - Alberts, Victor P.
AU - Lamme, Bas
AU - Wijsman, Jan H.
AU - Tuynman, Jurriaan B.
AU - Aalbers, Arend G. J.
AU - Beets, Geerard L.
AU - Fabry, Hans F. J.
AU - Cherepanin, Ivan M.
AU - Polat, Fatih
AU - Burger, Jacobus W. A.
AU - Rutten, Harm J. T.
AU - Bosker, Robert J.
AU - Talsma, Koen
AU - Rothbarth, Joost
AU - Verhoef, Cees
AU - van de Ven, Anthony W. H.
AU - van der Bilt, Jarmila D. W.
AU - de Graaf, Eelco J. R.
AU - Doornebosch, Pascal G.
AU - Leijtens, Jeroen W. A.
AU - Heemskerk, Jeroen
AU - Singh, Baljit
AU - Chaudhri, Sanjay
AU - Gerhards, Michael F.
AU - Karsten, Tom M.
AU - de Wilt, Johannes H. W.
AU - Bremers, Andre J. A.
AU - Vuylsteke, Ronald J. C. L. M.
AU - Heuff, Gijsbert
AU - van Geloven, Anna A. W.
AU - Tanis, Pieter J.
AU - Musters, Gijsbert D.
N1 - Funding Information:
This study is funded by the Dutch Cancer Society (‘KWF Kankerbestrijding’), a Dutch foundation dedicated to combat against cancer through scientific research, counselling, patient support and fundraising. The funder has no influence on the content or execution of the project. Trial Sponsor: KWF Kankerbestrijding Address: Team Bestedingen, Postbus 75508, 1070 AM Amsterdam Telephone: 0031 20 - 570 04 50 Email: [email protected]
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/7/23
Y1 - 2020/7/23
N2 - 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.
AB - 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.
KW - Abdominoperineal resection
KW - Rectal cancer
KW - Primary perineal wound closure
KW - Gluteal turnover flap
KW - Perineal wound infection and perineal wound healing
KW - PELVIC FLOOR
KW - THIGH FLAP
KW - RECONSTRUCTION
KW - REPAIR
U2 - 10.1186/s12893-020-00823-7
DO - 10.1186/s12893-020-00823-7
M3 - Article
C2 - 32703182
SN - 1471-2482
VL - 20
JO - BMC Surgery
JF - BMC Surgery
IS - 1
M1 - 164
ER -