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 I Bosker; Koen Talsma; Joost Rothbarth; Cees Verhoef; Anthony 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

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
, 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 I Bosker
, Koen Talsma
, Joost Rothbarth
, Cees Verhoef

Anthony 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

Surgery

University of Amsterdam
Albert Schweitzer Hospital
Amphia Hospital
Burgas Free University
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Bravis Hospital
Canisius Wilhelmina Hospital
Catharina Hospital
Deventer Hospital
Flevo Hospital
IJsselland Hospital
Laurentius Hospital
Leicester City Hospital
OLVG Hospital
Radboud University Medical Center
Department of Surgery
Tergooi Ziekenhuis
Amsterdam UMC

Research output: Contribution to journal › Article › Academic › peer-review

17 Citations (Scopus)

65 Downloads (Pure)

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.

Original language	English
Article number	164
Pages (from-to)	164
Journal	BMC Surgery
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12893-020-00823-7
Publication status	Published - 23 Jul 2020

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research programs

EMC OR-01

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http://hdl.handle.net/1765/129230

Cite this

Sharabiany, S., Blok, R. D., Lapid, O., Hompes, R., Bemelman, W. A., Alberts, V. P., Lamme, B., Wijsman, J. H., Tuynman, J. B., Aalbers, A. G. J., Beets, G. L., Fabry, H. F. J., Cherepanin, I. M., Polat, F., Burger, J. W. A., Rutten, H. J. T., Bosker, R. J. I., Talsma, K., Rothbarth, J., ... Musters, G. D. (2020). 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). BMC Surgery, 20(1), 164. Article 164. https://doi.org/10.1186/s12893-020-00823-7

@article{bc507cb10eb34396abc79eb3646d4236,

title = "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)",

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.",

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

year = "2020",

month = jul,

day = "23",

doi = "10.1186/s12893-020-00823-7",

language = "English",

volume = "20",

pages = "164",

journal = "BMC Surgery",

issn = "1471-2482",

publisher = "BioMed Central Ltd.",

number = "1",

}

Sharabiany, S, Blok, RD, Lapid, O, Hompes, R, Bemelman, WA, Alberts, VP, Lamme, B, Wijsman, JH, Tuynman, JB, Aalbers, AGJ, Beets, GL, Fabry, HFJ, Cherepanin, IM, Polat, F, Burger, JWA, Rutten, HJT, Bosker, RJI, Talsma, K, Rothbarth, J , Verhoef, C, van de Ven, AWH, van der Bilt, JDW, de Graaf, EJR, Doornebosch, PG, Leijtens, JWA, Heemskerk, J, Singh, B, Chaudhri, S, Gerhards, MF, Karsten, TM, de Wilt, JHW, Bremers, AJA, Vuylsteke, RJCLM, Heuff, G, van Geloven, AAW, Tanis, PJ & Musters, GD 2020, '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)', BMC Surgery, vol. 20, no. 1, 164, pp. 164. https://doi.org/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). / Sharabiany, Sarah; Blok, Robin D; Lapid, Oren et al.
In: BMC Surgery, Vol. 20, No. 1, 164, 23.07.2020, p. 164.

Research output: Contribution to journal › Article › Academic › peer-review

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 I

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

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

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

U2 - 10.1186/s12893-020-00823-7

DO - 10.1186/s12893-020-00823-7

M3 - Article

C2 - 32703182

SN - 1471-2482

VL - 20

SP - 164

JO - BMC Surgery

JF - BMC Surgery

IS - 1

M1 - 164

ER -

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)

Abstract

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