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NOT YET RECRUITING
NCT06943690
NA

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2025-05

Completion Date

2027-06

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (4)

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China