NCT06591572

Single-port Robotic Transanal Total Mesorectal Excision

Efficacy and Safety Assessment of Single-port Robotic Transanal Total Mesorectal Excision for Mid and Low Rectal Cancer: a Phase 2a Trial Based on the IDEAL Framework

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathological indices of SPr-taTME in the treatment of mid-to-low rectal cancer.

Conditions

• Rectal Cancer Patients

Interventions

Type	Name	Description
PROCEDURE	Single-port robotic transanal total mesorectal excision	Rectal resection by transanal TME with single-port robotic surgery

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-04-01
• Completion: 2025-09-01
• First posted: 2024-09-19
• Last updated: 2025-09-17

Locations

1 site across 1 country: China