Professor Philippe Rouanet, internationally renowned expert in minimally invasive and robotic surgery and experienced proctor in robotic surgery at the Institut du Cancer de Montpellier (ICM), shares the latest news, as chief investigator of the RESET study.
Rectal cancer is relatively common, with almost 40,000 new cases estimated for 2017 in the US alone. The standard of care for its treatment is total mesorectal excision (TME), the en bloc sharp dissection of the tumor and the mesorectum (the surrounding perirectal lymphatic tissue located within a thin fascial layer) under direct vision. TME has reduced local recurrence rates and improved overall survival. When combined with low anterior resection (LAR), the technique is used to excise tumours in the lower two-thirds of the rectum, a technically challenging surgery due to a narrow pelvis and difficulties in obtaining adequate exposure.
The Rectal Surgery Evaluation Trial (RESET) is a prospective, observational, case-matched, four-cohort, multicenter 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 are performed by surgeons experienced in a technique. Oncologic, 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 endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.