Top

Published in:

01-12-2020 | Wound Infection | Study protocol

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)

Authors: 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

Published in: BMC Surgery | Issue 1/2020

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.

Musters GD, Buskens CJ, Bemelman WA, Tanis PJ. Perineal wound healing after abdominoperineal resection for rectal cancer: a systematic review and meta-analysis. Dis Colon Rectum. 2014;57(9):1129–39.PubMedCrossRef

Musters GD, Klaver CEL, Bosker RJI, Burger JWA, van Duijvendijk P, van Etten B, et al. Biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer: a multicenter randomized controlled trial (the BIOPEX-study). Ann Surg. 2017;265(6):1074–81.PubMedCrossRef

Blok RD, de Jonge J, de Koning MA, van de Ven AWH, van der Bilt JDW, van Geloven AAW, et al. Propensity score adjusted comparison of pelviperineal morbidity with and without omentoplasty following abdominoperineal resection for primary rectal cancer. Dis Colon Rectum. 2019;62(8):952–9.PubMedCrossRef

Devulapalli C, Jia Wei AT, DiBiagio JR, Baez ML, Baltodano PA, Seal SM, et al. Primary versus flap closure of perineal defects following oncologic resection: a systematic review and meta-analysis. Plast Reconstr Surg. 2016;137(5):1602–13.PubMedCrossRef

Blok RD, Hagemans JAW, Burger JWA, Rothbarth J, van der Bilt JDW, Lapid O, et al. Feasibility of a subcutaneous gluteal turnover flap without donor site scar for perineal closure after abdominoperineal resection for rectal cancer. Tech Coloproctol. 2019;23(8):751–9.PubMedPubMedCentralCrossRef

Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH, et al. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002;20(7):1729–34.PubMedCrossRef

Blok RD, Kacmaz E, Hompes R, Lapid O, Bemelman WA, Tanis PJ. Gluteal turnover flap for perineal reconstruction following abdominoperineal resection for rectal cancer - a video vignette. Color Dis. 2019;21(9):1094–5.CrossRef

Chasapi M, Maher M, Mitchell P, Dalal M. The perineal turnover perforator flap: a new and simple technique for perineal reconstruction after extralevator abdominoperineal excision. Ann Plast Surg. 2018;80(4):395–9.PubMedCrossRef

Anderin C, Martling A, Lagergren J, Ljung A, Holm T. Short-term outcome after gluteus maximus myocutaneous flap reconstruction of the pelvic floor following extra-levator abdominoperineal excision of the rectum. Color Dis. 2012;14(9):1060–4.CrossRef

10.

Ando H, Ito K, Torii S, Kasai Y, Akiyama S, Nakao A. Pedicle myocutaneous flaps for reconstruction following total pelvic exenteration of intrapelvic recurrent rectal cancer: report of a case. Surg Today. 2001;31(4):363–6.PubMedCrossRef

11.

Hurwitz DJ, Swartz WM, Mathes SJ. The gluteal thigh flap: a reliable, sensate flap for the closure of buttock and perineal wounds. Plast Reconstr Surg. 1981;68(4):521–32.PubMedCrossRef

12.

Kimata Y, Uchiyama K, Ebihara S, Sakuraba M, Iida H, Nakatsuka T, et al. Anterolateral thigh flap donor-site complications and morbidity. Plast Reconstr Surg. 2000;106(3):584–9.PubMedCrossRef

13.

McCraw JB, Massey FM, Shanklin KD, Horton CE. Vaginal reconstruction with gracilis myocutaneous flaps. Plast Reconstr Surg. 1976;58(2):176–83.PubMedCrossRef

14.

Barrie J, Haque A, Evans DA. Perineal closure following extralevator abdominoperineal excision for cancer of the rectum. Color Dis. 2018;20(11):981–5.CrossRef

15.

Vermaas M, Ferenschild FT, Hofer SO, Verhoef C, Eggermont AM, de Wilt JH. Primary and secondary reconstruction after surgery of the irradiated pelvis using a gracilis muscle flap transposition. Eur J Surg Oncol. 2005;31(9):1000–5.PubMedCrossRef

16.

Spasojevic M, Mariathasan AB, Goscinski M, Thorgersen EB, Solbakken AM, Gullestad HP, et al. Vertical rectus abdominis musculocutaneous flap repair improves perineal wound healing after abdominoperineal resection for irradiated locally advanced rectal cancer. Ann Surg Oncol. 2018;25(5):1357–65.PubMedCrossRef

17.

Ng RW, Chan JY, Mok V, Li GK. Clinical use of a pedicled anterolateral thigh flap. J Plast Reconstr Aesthet Surg. 2008;61(2):158–64.PubMedCrossRef

18.

Mjoli M, Sloothaak DA, Buskens CJ, Bemelman WA, Tanis PJ. Perineal hernia repair after abdominoperineal resection: a pooled analysis. Color Dis. 2012;14(7):e400–6.CrossRef

19.

Rutegard M, Rutegard J, Haapamaki MM. Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study. BMJ Open. 2019;9(5):e027255.PubMedPubMedCentralCrossRef

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)
Authors: 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
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Wound Infection
Rectal Cancer
Rectal Cancer
Published in: BMC Surgery / Issue 1/2020
Electronic ISSN: 1471-2482
DOI: https://doi.org/10.1186/s12893-020-00823-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2020

Trans-hiatal repair for Oesophageal and Junctional perforation: a case series

Temporary pacemaker insertion for severe bradycardia following pneumoperitoneum during robot-assisted radical prostatectomy: a case report

Intrahepatic cholangiocarcinoma – influence of resection margin and tumor distance to the liver capsule on survival

How breast cancer treatments affect the quality of life of women with non-metastatic breast cancer one year after surgical treatment: a cross-sectional study in Greece

Two lucky survivors of thoracic impalement in childhood: case report and literature review

A rare serious case of retroperitoneal paraganglioma misdiagnosed as duodenal gastrointestinal stromal tumor: a case report