Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery

NCT06943690 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Not applicable

Started

2025-05

Last updated

2025-04-24

Condition(s) studied

Rectal CancerSurgery

Investigational drug(s) / intervention(s)

Single-port robotic surgeryMulti-port robotic surgery

Single-port robotic surgery: In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision.

Multi-port robotic surgery: In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision.

Study summary

This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 18 years \< age ≤80 years * Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge) * Pathological rectal carcinoma * Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual * Tumor size of 10 cm or less * No history of other malignant tumors * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent Exclusion Criteria: * Body mass index (BMI) \>35 kg/m2 * Familial adenomatous polyposis (FAP) * Inflammatory bowel disease (IBD) * Multiple malignant colorectal tumors * Pregnant woman or lactating woman * Severe mental disease * Previous gastrointestinal surgery (except appendectomy ） * Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery * Requirement of simultaneous surgery for other disease * Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery. * Patients or family members who cannot understand the study program.

Primary outcome measure(s)

Surgical success rate — intraoperative
Proportion of robotic procedures not converted to laparoscopic or open surgery

Trial sites (4)

Facility	City	Region
The First Affiliated Hospital of Henan University of Science & Technology	Luoyang	Henan
Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai Municipality
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943690 on ClinicalTrials.gov ↗ ← All trials in China