Single-port Robotic Transanal Total Mesorectal Excision

NCT06591572 | Completed DMC

• 1 other identifier: SPORTS-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer Patients

Keywords

Single-port robotic; transanal total mesorectal excision; rectal cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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 .

  Intraoperative

Secondary Outcomes (2)

• Quality of specimen (as proposed and published by Quirke et al)

  7 days after surgery

• Operative time

  Date of surgery (Day 1)

Study Arms (1)

Single-port robotic transanal total mesorectal excision

EXPERIMENTAL

Single-port robotic transanal total mesorectal excision

Procedure: Single-port robotic transanal total mesorectal excision

Interventions

Single-port robotic transanal total mesorectal excision PROCEDURE

Rectal resection by transanal TME with single-port robotic surgery

Single-port robotic transanal total mesorectal excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Huichao Zheng

Chongqing, 400042, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fan Li, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: September 19, 2024
• Study Start: October 24, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 17, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)