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

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.

Conditions

• Cervical Cancer Stage IB2
• Cervical Cancer Stage IIa

Interventions

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

Sponsors & Collaborators

• Ajou University School of Medicine

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Konkuk University

  collaborator OTHER

• DongGuk University

  collaborator OTHER

• Keimyung University

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• The Catholic University of Korea

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Sinchon Severance Hospital, Yonsei University College of Medicine

  collaborator UNKNOWN

• Seoul National University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2034-12-31

Completion

2035-06-30

FDA Device

Yes

Countries

• South Korea

Study Locations