Transanal vs Robotic Total Mesorectal Excision for Low Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-controlled trial compares transanal total mesorectal excision (taTME) with robot-assisted total mesorectal excision (rTME) in adults with low rectal cancer. The primary endpoint is intraoperative conversion rate, with secondary focus on complications and the ability to preserve the sphincter. Eligible participants have confirmed adenocarcinoma of the rectum, tumor within 7 cm of the anal verge, and suitable performance status. Surgeries are conducted at a single leading center in Guangzhou, China, with standard perioperative care. The goal is to generate high-level evidence to guide surgical decision-making for sphincter-preserving options.

Why it matters

Who can join: the full rules

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.

Where it's running

• the sixth affiliated hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Liang Kang — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Liang Kang, MD
• Email: kangl@mail.sysu.edu.cn
• Phone: +8613602886833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.