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)
Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)
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)
Single group
Minimally invasive surgery using endoscopic stapler
Procedure/SurgeryRadical 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.
4.5 year disease-free survival [DFS] rate
Probability of no recurrence from the day of surgery until post-operative 4.5 years
4.5 year overall survival [OS] rate
Rate of survival from the day of surgery until post-operative 4.5 years
Pattern of recurrence sites
Anatomical site of recurrent cancer according to imaging modalities
Morbidity
Intra-operative and post-operative complications occurring in less than post-operative 4 weeks and between post-operative 4 and 6 weeks. Other morbidity include estimated blood loss during surgery, post-operative pain and amount of analgesic consumption
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Seoul National University Hospital
Lead sponsor
Johnson & Johnson
Collaborator
