Rectal Cancer Patients
Conditions
Keywords
Single-port robotic, transanal total mesorectal excision, rectal cancer
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.
Interventions
PROCEDURESingle-port robotic transanal total mesorectal excision
Rectal resection by transanal TME with single-port robotic surgery
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed