Evidence map›Paper›PMID 32703182›Full record

ArticleBMC surgery2020

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 and 27 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04004650 (Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04004650 naunknown statusnot on this map

Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2019 to 2022Enrolled160ConditionsWound Heal, Abdominoperineal Resection, Rectal CancerArmsGluteal turnover flap
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Management of Perineal Wounds Following Pelvic Surgery.Clinics in colon and rectal surgery · 2022
    Review
  8. Article
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors at 18 institutions in 2 countries.

Sarah SharabianyDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands. s.sharabiany@amsterdamumc.nl.ORCID http://orcid.org/0000-0003-2222-2037
Robin D BlokDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Oren LapidDepartment of Plastic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Roel HompesDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Wilhelmus A BemelmanDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Victor P AlbertsDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Bas LammeDepartment of Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
Jan H WijsmanDepartment of Surgery, Amphia Hospital, Breda, The Netherlands.
Jurriaan B TuynmanDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, Free University, Amsterdam, The Netherlands.
Arend G J AalbersDepartment of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, The Netherlands.
Geerard L BeetsDepartment of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, The Netherlands.
Hans F J FabryDepartment of Surgery, Bravis Hospital, Roosendaal, The Netherlands.
Ivan M CherepaninDepartment of Surgery, Bravis Hospital, Roosendaal, The Netherlands.
Fatih PolatDepartment of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
Jacobus W A BurgerDepartment of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Harm J T RuttenDepartment of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Robert J I BoskerDepartment of Surgery, Deventer Hospital, Deventer, The Netherlands.
Koen TalsmaDepartment of Surgery, Deventer Hospital, Deventer, The Netherlands.
Joost RothbarthDepartment of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.
Cees VerhoefDepartment of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.
Anthony W H van de VenDepartment of Surgery, Flevo Hospital, Almere, The Netherlands.
Jarmila D W van der BiltDepartment of Surgery, Flevo Hospital, Almere, The Netherlands.
Eelco J R de GraafDepartment of Surgery, IJsselland Hospital, Capelle aan den Ijssel, The Netherlands.
Pascal G DoorneboschDepartment of Surgery, IJsselland Hospital, Capelle aan den Ijssel, The Netherlands.
Jeroen W A LeijtensDepartment of Surgery, Laurentius Hospital, Roermond, The Netherlands.
Jeroen HeemskerkDepartment of Surgery, Laurentius Hospital, Roermond, The Netherlands.
Baljit SinghDepartment of Surgery, Leicester Hospital, Leicester, UK.
Sanjay ChaudhriDepartment of Surgery, Leicester Hospital, Leicester, UK.
Michael F GerhardsDepartment of Surgery, OLVG Hospital, Amsterdam, The Netherlands.
Tom M KarstenDepartment of Surgery, OLVG Hospital, Amsterdam, The Netherlands.
Johannes H W de WiltDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
Andre J A BremersDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
Ronald J C L M VuylstekeDepartment of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.
Gijsbert HeuffDepartment of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.
Anna A W van GelovenDepartment of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
Pieter J TanisDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Gijsbert D MustersDepartment of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLRadboud University Nijmegen · NLBravis Ziekenhuis · NLDe Kinderkliniek · NLDeventer Ziekenhuis · NLErasmus University Rotterdam · NLIJsselland Ziekenhuis · NLLaurentius Ziekenhuis · NLLeicester General Hospital · GBOLVG · NLSpaarne Gasthuis · NLThe Netherlands Cancer Institute · NLAlbert Schweitzer Ziekenhuis · NLAmphia Ziekenhuis · NLAmsterdam Neuroscience · NLCanisius-Wilhelmina Ziekenhuis · NLOncode Institute · NLTergooi · NL

Funding

KWF Kankerbestrijding 11923
6 · The paper itself

Abstract

backgroundAbdominoperineal 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.

methodsPatients 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 registrationThe trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Indexed as

ProctectomyRectal NeoplasmsSurgical FlapsWound Closure TechniquesButtocksChondroitin SulfatesHumansHydroxyapatitesMulticenter Studies as TopicNeoplasm Recurrence, LocalPerineumQuality of LifeRandomized Controlled Trials as TopicResearch DesignSingle-Blind MethodSuccinatesBiopexChondroitin SulfatesHydroxyapatitesSuccinatesAbdominoperineal resectionGluteal turnover flapPerineal wound infection and perineal wound healingPrimary perineal wound closureRectal cancer

Identifiers

PMID32703182
PMCPMC7376711
OpenAlexW3045398045

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.