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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)