Single-port Robotic Transanal Total Mesorectal Excision

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer Patients

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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 .

Time frame: Intraoperative

Secondary Outcomes

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

Time frame: 7 days after surgery

Operative time

Record the total operation time, robotic docking time, transanal TME dissection time, and transabdominal TME dissection time respectively.

Time frame: Date of surgery (Day 1)