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Rectal Surgery Evaluation Trial (RESET)

NCT03574493 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1098

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

TME with LAR

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

Sponsors & Collaborators

  • Intuitive Surgical

    collaborator INDUSTRY

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Philippe ROUANET, MD · ICM Co. Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574493 on ClinicalTrials.gov