Single-port Robotic Transanal Total Mesorectal Excision

Not Applicable

Recruiting

• Conditions: Rectal Cancer Patients
• Interventions: Procedure: Single-port robotic transanal total mesorectal excision; Procedure: Laparoscopic transanal total mesorectal excision

• Registration Number: NCT06591572
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-11
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-07
• Study First Posted: 2024-09-19
• Study Start: 2024-10-24
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• (1) Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition); (2) Histological biopsy showing adenocarcinoma; (3) Stage I-III (MRI and abdominal CT), including the downstaged after neoadjuvant therapy; (4) Intention for primary anastomosis; (5) Obtain the informed consent of the patient and his family; (6) Suitable for robotic or laparoscopic surgery. (7) Over 18 years old.

Exclusion Criteria

1. 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) ;
2. The anal sphincter complex or levator anal muscle is involved;
3. Previous prostate or rectal surgery (excluding local excision) ;
4. Emergency surgery was performed due to complications of a rectal tumor;
5. Malignancy other than adenocarcinoma at histological examination;
6. Pregnancy;
7. Signs of acute intestinal obstruction;
8. Multiple colorectal tumours;
9. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis;
10. Planned synchronous abdominal organ resections;
11. Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
12. Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class > III)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-port robotic transanal total mesorectal excision	Single-port robotic transanal total mesorectal excision	Single-port robotic transanal total mesorectal excision
Laparoscopic transanal total mesorectal excision	Laparoscopic transanal total mesorectal excision	Laparoscopic transanal total mesorectal excision

Primary Outcome Measures

Name	Time	Method
Intraoperative adverse events and 30-day postoperative complications	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.
Conversion rate	Intraoperative	Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .

Secondary Outcome Measures

Name	Time	Method
Quality of specimen (as proposed and published by Quirke et al)	7 days after surgery	Quality of specimen (as proposed and published by Quirke et al)
Operative time	Date of surgery (Day 1)	Record the total operation time, robotic docking time, transanal TME dissection time, and transabdominal TME dissection time respectively.

Trial Locations

Locations (1)

Huichao Zheng; 🇨🇳 Chongqing, China