Single-port robotic surgery for rectal cancer

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

This study is testing a new robotic surgery method for people with mid-to-low rectal cancer to see if it is safe and effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT06591572 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of single-port robotic transanal total mesorectal excision (SPr-taTME) for patients with mid-to-low rectal cancer. It focuses on assessing intraoperative adverse events, postoperative complications, and the quality of surgical specimens. The approach utilizes a robotic system for transanal surgery, with the option for laparoscopic assistance. The study aims to determine the feasibility of this innovative surgical technique within the IDEAL framework.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with mid or low rectal cancer, specifically adenocarcinoma located 0-10 cm from the anal verge.

Not a fit: Patients with advanced tumors involving critical structures, previous rectal surgeries, or other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for rectal cancer patients.

How similar studies have performed: While this approach is innovative, similar robotic surgical techniques have shown promise in other studies, suggesting potential for success.

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)

Where this trial is running

Chongqing

• Huichao Zheng — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Fan Li, MD

Conditions Rectal Cancer Patients; Single-port robotic; transanal total mesorectal excision; rectal cancer