RecruitingNot ApplicableNCT04370496

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

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


Sponsor

Seoul National University Hospital

Enrollment

124 participants

Start Date

Jul 2, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether minimally invasive surgery using an endoscopic stapler device is safe and effective for early-stage cervical cancer. It compares outcomes to open surgery, examining whether this newer approach achieves similar cancer control with fewer complications. **You may be eligible if:** - You are a woman aged 20 or older - You have confirmed early-stage cervical cancer (FIGO stage IB1) — a tumor larger than 5mm deep or 7mm wide but not larger than 4 cm - Your cancer is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma - You are scheduled for a specific type of radical hysterectomy (Querleu-Morrow type B or C) - Your blood counts, kidney function, and liver function are within acceptable ranges - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if:** - Your cancer is more advanced than stage IB1 - You have cancer involving other organs simultaneously - Your blood or organ function tests are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMinimally 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

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NCT04370496


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