NCT03574493Completed
Rectal Surgery Evaluation Trial (RESET)
Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1098 (actual)
- First submitted
- 20 Jun 2018
- Start date
- 16 Oct 2018
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Colorectal cancer
- NCT number
- NCT03574493
What you commit to
- Study type: Observational
- Participants enrolled: 1098
- From 16 Oct 2018 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient requires an abdominal perineal resection (APR)
- Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
- Patient included in another study which impact on the surgical technique or its choice.
Other illness
- Patient with a comorbid illness or condition that would preclude the use of surgery.
- Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
- Metastatic disease
Other
- Patients with T4b tumors which impose a pelvectomy
- Patient undergoing emergency procedures
- Pregnant or suspected pregnancy
- Patients unwilling to comply with all follow-up study requirements
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.