P Rouanet1, S Gourgou2, I Gogenur3, D Jayne4, A Ulrich5, T Rautio6, G Spinoglio7, N Bouazza8, A Moussion8, M Gomez Ruiz9. 1. Surgery Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 2. Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 3. Zealand University Hospital, Roskilde, Denmark. 4. St James University Hospital, Leeds, UK. 5. Department of Surgery, Lukaskrankenhaus Neuss, Neuss, Germany. 6. Oulu University Hospital, Oulu, Finland. 7. IEO European Institute of Oncology, Milan, Italy. 8. Clinical Research Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France. 9. Cirugía Colorrectal - Cirugía General y del Aparato Digestivo, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
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. Colorectal Disease
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. Colorectal Disease
Authors: Karin Atgm Wasmann; Charlotte El Klaver; Jarmila Dw van der Bilt; Susan van Dieren; Iris D Nagtegaal; Cornelis Ja Punt; Bert van Ramshorst; Albert M Wolthuis; Johannes Hw de Wilt; André D'Hoore; Hjalmar C van Santvoort; Pieter J Tanis Journal: Cancer Manag Res Date: 2019-07-29 Impact factor: 3.989