Rectal Surgery Evaluation Trial (RESET)

The Rectal Surgery Evaluation Trial will be 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 will be 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.

Inclusion criteria

• Age ≥ 18 years old
• Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
• High risk operative patients (two of these factors as assessed on MRI):

• Obese patient with a BMI > 30 (male or female)
• Narrow pelvis: inter-tuberous distance < 10 cm
• Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
• Expected coloanal or ultra-low colorectal anastomosis
• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
• Patient has signed and dated the informed consent before inclusion in the study.

Exclusion criteria

• Patient with a comorbid illness or condition that would preclude the use of surgery.
• Patients with T4b tumors which impose a pelvectomy
• Patient requires an abdominal perineal resection (APR)
• Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
• Patient undergoing emergency procedures
• Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
• Metastatic disease
• Pregnant or suspected pregnancy
• Patients unwilling to comply with all follow-up study requirements
• Patient included in another study which impact on the surgical technique or its choice.