CompletedNot Applicable

Single-port Robotic Transanal Total Mesorectal Excision

China20 participantsStarted 2024-10-24

Plain-language summary

This is a phase 2a clinical trial based on the IDEAL framework to evaluate the safety, feasibility and clinical efficacy of single-port robotic transanal total mesorectal excision (SPr-taTME )surgery. For safety, intraoperative adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. The transanal surgical platform consists of a single-port robotic system, while the transabdominal approach can be performed laparoscopically or with single-port robotic assistance.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRI-scan (staged after (chemo)radiotherapy if applicable) ;
✕. The anal sphincter complex or levator anal muscle is involved;
✕. Previous prostate or rectal surgery (excluding local excision) ;
✕. Emergency surgery was performed due to complications of a rectal tumor;
✕. Malignancy other than adenocarcinoma at histological examination;
✕. Pregnancy;
✕. Signs of acute intestinal obstruction;
✕. Multiple colorectal tumours;

What they're measuring

Intraoperative adverse events and 30-day postoperative complications

Timeframe: Intraoperative and postoperative 30 days

Conversion rate

Timeframe: Intraoperative

Trial details

NCT IDNCT06591572

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

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