NCT05468944

Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Taiyuan Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

Detailed description

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Conditions

• Rectal Neoplasms
• Robotic Surgery
• Natural Orifice Specimen Extraction Surgery

Interventions

Type	Name	Description
PROCEDURE	Transanal specimen extraction robotic surgery	Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
PROCEDURE	Transabdominal specimen extraction robotic surgery	Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

12 sites across 1 country: China