Safety Of Laparoscopic or robotic radical hysterectomy Using endoscopic sTapler for Inhibiting tumOr spillage of cervical Neoplasms (SOLUTION): a phase II study

Not Applicable

Not yet recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0005045
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

? 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 Criteria

? 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 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 in pregnancy
? Patients with a history of pelvic or abdominal radiotherapy
? Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)
? 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4.5 year disease-free survival [DFS] rate

Secondary Outcome Measures

Name	Time	Method
4.5 year overall survival [OS] rate;Pattern of recurrence sites;Morbidity