Rectal Surgery Evaluation Trial (RESET) (NCT03574493) | Clinical Trial Compass
CompletedNot Applicable
Rectal Surgery Evaluation Trial (RESET)
France1,098 participantsStarted 2018-10-16
Plain-language summary
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 surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.
Who can participate
Age range18 Years
SexALL
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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)
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
What they're measuring
1
Efficacy of surgical method (success determined by composite of Oncologic, morbidity and functional outcomes)
Timeframe: up to 4 years
Trial details
NCT IDNCT03574493
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle