Rectal Surgery Evaluation Trial (RESET) V1.2
Research type
Research Study
Full title
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
IRAS ID
255053
Contact name
Jim Khan
Contact email
Sponsor organisation
Institut regional du Cancer de Montpellier
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ICM-ENR-432, ICM Internal Reference number
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
This study is an observational, prospective, international, multicenter, 4-parallel-cohorts study comparing four surgical techniques used to treat mid-to-low rectal cancer in high-risk patients.
These 4 techniques are:
- Laparotomy (or open): surgical procedure involving a large incision through the abdominal wall to gain access to the abdominal cavity.
- Laparoscopy (lap): also called minimally-invasive surgery (MIS) or keyhole surgery; surgical technique in which operations are performed far from their location through small incisions (usually 0.5–1.5 cm) elsewhere in the body.
- Robotic-assisted surgery (RAS using the Da Vinci Surgical System): allows many types of complex MIS procedures using the robotic systems to aid the surgical procedures providing more precision, flexibility and control than is possible with the other MIS techniques. All RAS procedures will be performed using a Da Vinci Surgical System.
- TaTME surgery (Trans-anal TME) : Type of surgery for rectal cancer that is perform through the anus. This bottom-up surgery performs the proctectomy down to up, until the Douglas pouch.
The expected number of patients to be included is 1300 over 2 years in 10 countries, with a 2 year follow-up period.
The clinical data will be recovered from patients medical files including the medical history, previous and current treatments and any complications due to the surgery. All patient assessments will be done according to the sites standard of care.
Quality of life will also be monitored with validated questionnaires before surgery, and 30 days, 1 year and 2 years after the surgery. The questionnaires will evaluate global health and overall quality of life and the restoration of digestive, urinary and sexual functions after surgery.
The ambition of this work is to increase knowledge of all these surgical techniques for rectal cancer management, as to know which is the best surgical technique for a specific patient population.REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0310
Date of REC Opinion
12 Jul 2019
REC opinion
Favourable Opinion