KCT0005045
Not yet recruiting
未知
Safety Of Laparoscopic or robotic radical hysterectomy Using endoscopic sTapler for Inhibiting tumOr spillage of cervical Neoplasms (SOLUTION): a phase II study
ConditionsDiseases of The genitoruinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of The genitoruinary system
- Sponsor
- Seoul National University Hospital
- Enrollment
- 124
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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:
Outcomes
Primary Outcomes
Not specified
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