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RECRUITING
NCT04370496
NA

Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.

Official title: Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study

Key Details

Gender

FEMALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2020-07-02

Completion Date

2028-12-31

Last Updated

2023-06-26

Healthy Volunteers

No

Interventions

PROCEDURE

Minimally invasive surgery using endoscopic stapler

Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.

Locations (3)

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine

Suwon, South Korea