NCT07256977

Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer

A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 494 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.

Detailed description

This study exclusively includes patients with stage IB2 or IIA1 cervical cancer who have tumors measuring 2 cm or larger but less than 4 cm. After randomization, one group undergoes radical hysterectomy via open surgery, while the other group undergoes minimally invasive radical hysterectomy using an endoscopic stapler. This approach using an endoscopic stapler aims to prevent intraoperative exposure of tumor cells to the abdominal cavity, comparable to open surgery, thereby enabling a comparison of therapeutic efficacy and safety.

Conditions

• Cervical Cancer Stage IB2
• Cervical Cancer Stage IIa

Interventions

Type	Name	Description
DEVICE	Open radical hysterectomy	Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
DEVICE	Minimally invasive radical hysterectomy	Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

Timeline

• Start date: 2026-01-01
• Primary completion: 2034-12-31
• Completion: 2035-06-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study