University of Oulu

Rouanet, P. , Gourgou, S. , Gogenur, I. , Jayne, D. , Ulrich, A. , Rautio, T. , Spinoglio, G. , Bouazza, N. , Moussion, A. and Gomez Ruiz, M. (2019), Rectal Surgery Evaluation Trial: protocol for a parallel cohort trial of outcomes using surgical techniques for total mesorectal excision with low anterior resection in high‐risk rectal cancer patients. Colorectal Dis, 21: 516-522. doi:10.1111/codi.14581

Rectal Surgery Evaluation Trial : protocol for a parallel cohort trial of outcomes using surgical techniques for total mesorectal excision with low anterior resection in high‐risk rectal cancer patients

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Author: Rouanet, P.1; Gourgou, S.2; Gogenur, I.3;
Organizations: 1Surgery Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France
2Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France
3Zealand University Hospital, Roskilde, Denmark
4St James University Hospital, Leeds, UK
5Department of Surgery, Lukaskrankenhaus Neuss, Neuss, Germany
6Oulu University Hospital, Oulu, Finland
7IEO European Institute of Oncology, Milan, Italy
8Clinical Research Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France
9Cirugía Colorrectal – Cirugía General y del Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Santander, Spain
Format: article
Version: accepted version
Access: embargoed
Persistent link: http://urn.fi/urn:nbn:fi-fe2019050214015
Language: English
Published: John Wiley & Sons, 2019
Publish Date: 2020-02-10
Description:

Abstract

Aim: Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid‐to‐low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgery technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot‐assisted surgery and transanal surgery. Comparative data for these techniques are required to provide clinical data on the surgical management of rectal cancers.

Methods: The Rectal Surgery Evaluation Trial will be a prospective, observational, case‐matched, four‐cohort, multicentre trial designed to study TME with LAR using open laparotomy, laparoscopy, robot‐assisted surgery or transanal surgery in high‐surgical‐risk patients with mid‐to‐low non‐metastatic rectal cancer. All surgeries will be performed by surgeons experienced in at least one of the techniques. Oncological, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥ 1 mm, TME Grade III and minimal postoperative morbidity (absence of Clavien–Dindo Grade III–IV complications within 30 days after surgery). Secondary end‐points will include the co‐primary end‐points over the long term (2 years), quality of surgery, quality of life, length of hospital stay, operative time and rate of unplanned conversions.

Discussion: This will be the first trial to study all four surgical techniques currently used for TME with LAR in a specific group of high‐risk patients. The knowledge obtained will contribute towards helping physicians determine the advantages of each technique and which may be the most appropriate for their patients.

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Series: Colorectal disease
ISSN: 1462-8910
ISSN-E: 1463-1318
ISSN-L: 1462-8910
Volume: 21
Issue: 5
Pages: 516 - 522
DOI: 10.1111/codi.14581
OADOI: https://oadoi.org/10.1111/codi.14581
Type of Publication: A1 Journal article – refereed
Field of Science: 3126 Surgery, anesthesiology, intensive care, radiology
Subjects:
Funding: Financial support was provided by Intuitive Surgical, Aubonne, Switzerland.
Copyright information: Colorectal Disease © 2019 The Association of Coloproctology of Great Britain and Ireland. This is the peer reviewed version of the following article: Rouanet, P. , Gourgou, S. , Gogenur, I. , Jayne, D. , Ulrich, A. , Rautio, T. , Spinoglio, G. , Bouazza, N. , Moussion, A. and Gomez Ruiz, M. (2019), Rectal Surgery Evaluation Trial: protocol for a parallel cohort trial of outcomes using surgical techniques for total mesorectal excision with low anterior resection in high‐risk rectal cancer patients. Colorectal Dis, 21: 516-522. doi:10.1111/codi.14581, which has been published in final form at https://doi.org/10.1111/codi.14581. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.