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.
• 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