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Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Sponsor: Seoul National University Hospital
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
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