RecruitingNot ApplicableNCT07651553

Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision

A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer


Sponsor

Sun Yat-sen University

Enrollment

216 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

TME remains standard treatment for rectal cancer. Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • ECOG performance status 0-1. Informed consent obtained.

Exclusion Criteria1

  • Pregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.

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Interventions

PROCEDURErobotic surgery vs transanal total mesorectal excsion

This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)


Locations(1)

the sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07651553


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