Huichao Zheng
Chongqing, 400042, China
NCT Number: NCT06591572
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.
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All sexes
Interventional
Not applicable
Chongqing, 400042, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rectal resection by transanal TME with single-port robotic surgery
Time frame: Intraoperative and postoperative 30 days
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
Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .
Time frame: 7 days after surgery
Quality of specimen (as proposed and published by Quirke et al)
Time frame: Date of surgery (Day 1)
Record the total operation time, robotic docking time, transanal TME dissection time, and transabdominal TME dissection time respectively.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Other
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
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