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)

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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.

Related collections

Most cited references 19

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Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control.

J Dalén, Phil Quirke, … (2002)

Quality assessment and assurance are important issues in modern health care. For the evaluation of surgical procedures, there are indirect parameters such as complication, recurrence, and survival rates. These parameters are of limited value for the individual surgeon, and there is an obvious need for direct parameters. We have evaluated criteria by which pathologists can judge the quality or completeness of the resection specimen in a randomized trial for rectal cancer. The pathology reports of all patients entered onto a Dutch multicenter randomized trial were reviewed. All participating pathologists had been instructed by workshops and videos in order to obtain standardized pathology work-up. A three-tiered classification was applied to assess completeness of the total mesorectal excision (TME). Prognostic value of this classification was tested using log-rank analysis of Kaplan-Meier survival curves using the data of all patients who did not receive any adjuvant treatment. Included were 180 patients. In 24% (n = 43), the mesorectum was incomplete. Patients in this group had an increased risk for local and distant recurrence, 36.1% v. 20.3% recurrence in the group with a complete mesorectum (P =.02). Follow-up is too short to observe an effect on survival rates. A patient's prognosis is predicted by applying a classification of macroscopic completeness on a rectal resection specimen. We conclude that pathologists are able to judge the quality of TME for rectal cancer. With this direct interdisciplinary assessment instrument, we establish a new role of the pathologist in quality control.

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Perineal wound healing after abdominoperineal resection for rectal cancer: a systematic review and meta-analysis.

Gijsbert Musters, Christianne J. Buskens, Willem Bemelman … (2014)

Impaired perineal wound healing has become a significant clinical problem after abdominoperineal resection for rectal cancer. The increased use of neoadjuvant radiotherapy and wider excisions might have contributed to this problem.

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Anterolateral thigh flap donor-site complications and morbidity.

H. Iida, Y Kimata, K. Harii … (2000)

The authors examined donor-site complications and morbidity in 37 patients after reconstruction with free or pedicled anterolateral thigh flaps. Intraoperative assessment included damage to the vastus lateralis muscle and whether the main pedicle of the rectus femoris muscle had been killed. Postoperative assessment of the donor site included wound healing, range of motion, muscle strength, gait, and sensation. Patients were surveyed with a questionnaire about fatigue in their activities of daily life and the appearance of the donor site. All 32 patients who underwent primary skin closure could perform activities of daily life normally, and most (87.5 percent) reported that donor-site appearance was satisfactory. However, the severity of donor-site dysfunction was related to the degree of damage to the vastus lateralis muscle, and most patients (87.5 percent) had some loss of sensation at the anterolateral aspect of the thigh. Because of adhesions between the meshed skin graft and the underlying fascia, range of motion at the hip and knee was limited in significantly more patients who had received split-thickness skin grafts (60 percent) than patients who had undergone primary skin closure (3.1 percent). Therefore, wider flaps or flaps harvested nearer the knee may increase donor-site morbidity. The authors concluded that the incidence of long-term morbidity with the anterolateral thigh flap is low, although it is increased when the flap includes the vastus lateralis muscle or is wider and requires additional skin grafting at the donor site.

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Author and article information

Contributors

Sarah Sharabiany:

ORCID: http://orcid.org/0000-0003-2222-2037

s.sharabiany@amsterdamumc.nl

Robin D. Blok: r.d.blok@amsterdamumc.nl

Roel Hompes: r.hompes@amsterdamumc.nl

Wilhelmus A. Bemelman: w.a.bemelman@amsterdamumc.nl

Pieter J. Tanis: p.j.tanis@amsterdamumc.nl

Gijsbert D. Musters: g.d.musters@amsterdamumc.nl

Journal

Journal ID (nlm-ta): BMC Surg

Journal ID (iso-abbrev): BMC Surg

Title: BMC Surgery

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2482

Publication date (Electronic): 23 July 2020

Publication date PMC-release: 23 July 2020

Publication date Collection: 2020

Volume: 20

Electronic Location Identifier: 164

Affiliations

[1 ]GRID grid.7177.6, ISNI 0000000084992262, Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, , University of Amsterdam, ; Amsterdam, The Netherlands

[2 ]GRID grid.7177.6, ISNI 0000000084992262, LEXOR, Centre for Experimental and Molecular Medicine, Oncode Institute, Cancer Centre Amsterdam, Amsterdam UMC, , University of Amsterdam, ; Amsterdam, The Netherlands

[3 ]GRID grid.7177.6, ISNI 0000000084992262, Department of Plastic Surgery, Amsterdam UMC, , University of Amsterdam, ; Amsterdam, The Netherlands

[4 ]GRID grid.413972.a, ISNI 0000 0004 0396 792X, Department of Surgery, , Albert Schweitzer Hospital, ; Dordrecht, the Netherlands

[5 ]GRID grid.413711.1, Department of Surgery, , Amphia Hospital, ; Breda, The Netherlands

[6 ]GRID grid.12380.38, ISNI 0000 0004 1754 9227, Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, , Free University, ; Amsterdam, The Netherlands

[7 ]GRID grid.430814.a, Department of Surgery, , Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, ; Amsterdam, The Netherlands

[8 ]Department of Surgery, Bravis Hospital, Roosendaal, The Netherlands

[9 ]GRID grid.413327.0, ISNI 0000 0004 0444 9008, Department of Surgery, , Canisius Wilhelmina Hospital, ; Nijmegen, The Netherlands

[10 ]GRID grid.413532.2, ISNI 0000 0004 0398 8384, Department of Surgery, , Catharina Hospital, ; Eindhoven, The Netherlands

[11 ]GRID grid.5012.6, ISNI 0000 0001 0481 6099, GROW School of Oncology and Developmental Biology, , University of Maastricht, ; Maastricht, The Netherlands

[12 ]GRID grid.413649.d, ISNI 0000 0004 0396 5908, Department of Surgery, , Deventer Hospital, ; Deventer, The Netherlands

[13 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Surgery, , Erasmus Medical Centre, ; Rotterdam, The Netherlands

[14 ]GRID grid.440159.d, Department of Surgery, , Flevo Hospital, ; Almere, The Netherlands

[15 ]GRID grid.414559.8, ISNI 0000 0004 0501 4532, Department of Surgery, , IJsselland Hospital, ; Capelle aan den Ijssel, The Netherlands

[16 ]GRID grid.415842.e, ISNI 0000 0004 0568 7032, Department of Surgery, , Laurentius Hospital, ; Roermond, The Netherlands

[17 ]Department of Surgery, Leicester Hospital, Leicester, UK

[18 ]Department of Surgery, OLVG Hospital, Amsterdam, The Netherlands

[19 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Surgery, , Radboud University Medical Centre, ; Nijmegen, The Netherlands

[20 ]GRID grid.416219.9, ISNI 0000 0004 0568 6419, Department of Surgery, , Spaarne Gasthuis, ; Haarlem, The Netherlands

[21 ]Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands

Author information

Sarah Sharabiany http://orcid.org/0000-0003-2222-2037

Article

Publisher ID: 823

DOI: 10.1186/s12893-020-00823-7

PMC ID: 7376711

PubMed ID: 32703182

SO-VID: 6f7c7c4e-71dd-49a7-9d33-01a851f64705

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 24 December 2019

Date accepted : 13 July 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004622, KWF Kankerbestrijding;

Award ID: 11923

Award Recipient : Pieter J. Tanis

Custom metadata

ScienceOpen disciplines: Surgery

Keywords: abdominoperineal resection,rectal cancer,primary perineal wound closure,gluteal turnover flap,perineal wound infection and perineal wound healing

Data availability:

ScienceOpen disciplines: Surgery

Keywords: abdominoperineal resection, rectal cancer, primary perineal wound closure, gluteal turnover flap, perineal wound infection and perineal wound healing

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)

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Abstract

Background

Methods

Discussion

Trial registration

Related collections

Karger: Oncology

Most cited references 19

Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control.

Perineal wound healing after abdominoperineal resection for rectal cancer: a systematic review and meta-analysis.

Anterolateral thigh flap donor-site complications and morbidity.

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