Status:
COMPLETED
Single-port Robotic Transanal Total Mesorectal Excision
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Rectal Cancer Patients
Eligibility:
All Genders
18+ years
Phase:
NA
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....
Detailed Description
The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathologica...
Eligibility Criteria
Inclusion
- (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
- 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)
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06591572
Start Date
October 24 2024
End Date
September 1 2025
Last Update
September 17 2025
Active Locations (1)
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1
Huichao Zheng
Chongqing, China, 400042