Single-port Versus Multi-port Robotic Surgery for Rectal Cancer

Not Applicable

Recruiting

• Conditions: Rectal Cancer Patients; Robotic Surgical Procedures

• Registration Number: NCT06824688
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Single-port versus multi-port robotic surgery for rectal cancer

Detailed Description

This study is a phase 2a clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-23
• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Rectal cancer with the lower tumor margin less than 15 centimeters from the anal verge (defined by MRI);
• Histological biopsy confirms adenocarcinoma of the rectum;
• Stage I-III (assessed by MRI and abdominal CT), including downstaging after neoadjuvant therapy;
• Intends to perform anal sphincter-preserving surgery and plans for primary anastomosis;
• Informed consent has been obtained from the patient and family;
• Age greater than 18 years old.

Exclusion Criteria

• Previous rectal resection (excluding local excision);
• Emergency surgery due to complications from rectal tumors;
• Pregnancy;
• Signs of acute intestinal obstruction;
• Multifocal colorectal tumors requiring multisegment bowel resection;
• Familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis;
• Planned synchronous resection of abdominal organs;
• History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
• Absolute contraindications to general anesthesia or prolonged abdominal insufflation, such as severe cardiovascular or respiratory diseases (ASA classification >III);
• Preoperative MRI suggests tumor invasion of the levator ani muscle or external anal sphincter, and preoperative assessment indicates inability to achieve curative resection or the need for abdominoperineal resection;
• Clinical or radiological evidence of distant metastasis of rectal cancer;
• Unsuitable for robotic surgery;
• Local excision of tumor;
• Anal cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of perioperative complications	Intraoperative and postoperative 30 days	Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days.
Number of participants with conversion procedures	Date of surgery (Day 1)	The number of patients converted from robotic to open or laparoscopic surgery

Secondary Outcome Measures

Name	Time	Method
Pain scores	Postoperative days 1-3	Visual Analog Scale (VAS) pain scores for patients on postoperative days 1-3
Quality of specimen	Date of surgery (Day 1)	As proposed and published by Quirke et al（Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.）
Total length of incisions	Date of surgery (Day 1)	Total length of all abdominal incisions (measured in millimeters).

Trial Locations

Locations (1)

Huichao Zheng; 🇨🇳 Chongqing, China