An interventional study of Single-port robotic transanal total mesorectal excision in Rectal Cancer Patients, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Not applicable, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 20 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Single-port robotic transanal total mesorectal excision
Procedure: Single-port robotic transanal total mesorectal excision
Rectal resection by transanal TME with single-port robotic surgery
Intraoperative adverse events and 30-day postoperative complications
Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days.
Time frame: Intraoperative and postoperative 30 days
Conversion rate
Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .
Time frame: Intraoperative
Quality of specimen (as proposed and published by Quirke et al)
Quality of specimen (as proposed and published by Quirke et al)
Time frame: 7 days after surgery
Operative time
Record the total operation time, robotic docking time, transanal TME dissection time, and transabdominal TME dissection time respectively.
Time frame: Date of surgery (Day 1)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University