CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,098 enrolled
Drug / intervention
TME with LARprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03574493
NCT03574493N/ACompleted

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

Institut du Cancer de Montpellier - Val d'Aurelle·observational·Posted Jul 2, 2018·Updated Feb 12, 2025

In Brief

An observational study evaluating TME with LAR for Rectal Cancer. Completed, enrolled 1,098 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesFrance
CollaboratorsIntuitive Surgical

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 2, 2018
Enrollment StartOct 16, 2018
Primary CompletionDec 31, 2022
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8 years ago

Interventions

TME with LARprocedure

Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME