NCT01893333Unknown不适用
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Incidence of bladder dysfunction after surgery
研究概览
简要总结
To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed cervical cancer
- •FIGO stage IA2-IIA
- •Diameter of tumor is less than 4cm on exam
- •One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
- •Age between 18-70
- •Performance status; GOG 0-1
- •Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase < normal X 3
- •Patient with informed consent
- •Exclusion creteria:
- •Small cell carcinoma
- •Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases
- •Prior chemotherapy or radiotherapy
- •Severe bladder funtion abnormality
- •Double primary malignant tumor
- •Psychiatric problems
- •Pregnant or breast feeding status
- •Legally unable to participate clinical trial
- •When there is a Doctor's decision that patient is unable to participate clinical trial
排除标准
- 未提供
结局指标
主要结局
Incidence of bladder dysfunction after surgery
时间窗: 5 days after the surgery
Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL
次要结局
- rectal & anal function after surgery(6, 12 months after surgery)
- Sexual function(6, 12 months after surgery)
- Quality of life(6, 12 months after surgery)
- operative time(immediately after surgery)
- amount of bleeding in operation(immediately after surgery)
- frequency of blood transfusion(within 1 week after surgery)
- amount of blood transfusion(within 1 week after surgery)
- postoperative complication(within 1 month after surgery)
- time from surgery to return to work(within 1 month after surgery)
- management cost(within 1 week after surgery)
- size of resected parametrial tissue(immediately after surgery)
- 2year disease free survival(2 year after treatment)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (2)
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