NCT07651553 Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision
| NCT ID | NCT07651553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Rectal Cancer Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2025-06-30 with a primary completion date of 2027-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria:Newly diagnosed patients aged 18-75 years. Pathologically confirmed adenocarcinoma (tubular, papillary, mucinous, or signet-ring). Tumor ≤7 cm from anal verge (MRI or DRE). Clinical stage T1-T3, N+, M0 (AJCC 8th ed.), suitable for sphincter-preserving TME. ASA score I-III. ECOG performance status 0-1. Informed consent obtained. \- Exclusion Criteria: Synchronous/metachronous colorectal cancers, local recurrence, or distant metastases. Bowel obstruction, perforation, bleeding requiring emergency surgery. Involvement of sphincter or adjacent organs requiring Inter-sphincter Resection (ISR). Poor preoperative anal function/incontinence. IBD or familial adenomatous polyposis (FAP). Pregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.
Contact & Investigator
Liang Kang
PRINCIPAL INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT07651553 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07651553 currently recruiting?
Yes, NCT07651553 is actively recruiting participants. Contact the research team at kangl@mail.sysu.edu.cn for enrollment information.
Where is the NCT07651553 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07651553 clinical trial?
NCT07651553 is sponsored by Sun Yat-sen University. The principal investigator is Liang Kang at Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 216 participants.
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