Tests keyhole surgery with a stapler for early cervical cancer
Tests keyhole surgery with a stapler in adults with early cervical cancer.
Plain-language title generated from the registry record
Registry title: Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Key facts
- Where
- Seoul and Suwon, South KoreaSee the 3 sites
Where in South Korea
- Samsung Medical Center, Sungkyunkwan University School of MedicineSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of MedicineSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT04370496
- Record updated
- 26 June 2023
- Original description
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.Read full original descriptionShow less
Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
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.
Inclusion: 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); : stromal invasion>5 mm or 7 mm <lesion size ≤4 cm; Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification); Patients with normal bone marrow, renal and hepatic function; WBC > 3.0x10\^9 cells/L; Platelets > 100x10\^9 cells/L; Serum creatinine ≤1.5 mg/dL; Serum total bilirubin <1.5 x normal range and AST/SGOT or ALT/SGPT <3 x normal range; ECOG performance status 0 or 1; Synchronous cancer with no evidence of recurrence during the past 5 years; Informed consent of patient.
Exclusion: Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator); Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes; Patients with a history of pelvic or abdominal radiotherapy; Patients who agree to intra-operative lymphatic mapping (IOLM) must not have:; Known allergies to triphenylmethane compounds; History of retroperitoneal surgery; History of pelvic irradiation; Cold knife or LEEP cone biopsy within 4 weeks of enrollment; 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); or lesion size> 4 cm (greater than IB2); Patients in pregnancy.