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

Ki vehet részt

• 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

Ki nem vehet részt

• 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