Single-port Robotic Transanal Total Mesorectal Excision

NCT ID: NCT06591572

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2025-09-01

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.

Conditions

Rectal Cancer Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-port robotic transanal total mesorectal excision

Single-port robotic transanal total mesorectal excision

Group Type: EXPERIMENTAL

Single-port robotic transanal total mesorectal excision

Intervention Type: PROCEDURE

Rectal resection by transanal TME with single-port robotic surgery

Interventions

Single-port robotic transanal total mesorectal excision

Rectal resection by transanal TME with single-port robotic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fan Li, MD

Role: STUDY_CHAIR

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

Locations

Huichao Zheng

Chongqing, , China

Countries

China

Other Identifiers

SPORTS-01

Identifier Type: -

Identifier Source: org_study_id