Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Females, aged 20 years or older

Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix

Patients with FIGO stage IB1 (FIGO staging 2009)

Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)

Disqualifiers

Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix

Tumor size greater than 4 cm

Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)

stromal invasion ≤5 mm and lesion size ≤7 mm (less than IA2)

Trial design

Treatments tested in this trial

  • Minimally invasive surgery using endoscopic stapler

Treatment groups

124 Participants
are divided into 1 treatment group

Locations

3
Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul South Korea
Seoul National University Hospital03080, Seoul South Korea
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine Suwon South Korea

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov