NCT01679483已完成不适用
THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of lymphocele an lymphatic ascites
研究概览
简要总结
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
- •FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
- •Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
- •Patients with adequate bone marrow, renal and hepatic function:
- •WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal
- •American Society of Anesthesiology Physical Status 0-1
- •Performance status of ECOG 0-2
- •Patient must be suitable candidates for surgery
- •Patients who have signed an approved Informed Consent
排除标准
- •Patients with a history of pelvic or abdominal radiotherapy;
- •Patients who are pregnant
- •Patients with contraindications to surgery;
- •Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- •Patient's compliance and geographic proximity that do not allow adequate follow-up.
- •Patients who undergo only lymph node sampling
研究组 & 干预措施
FloSeal group
Experimental
This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
干预措施: FloSeal application (Drug)
结局指标
主要结局
Incidence of lymphocele an lymphatic ascites
时间窗: within 1 year after surgery
次要结局
- Time interval from surgery to removal of closed drain system(with 2 weeks after surgery)
- Postoperative drain amount(with 2 weeks after surgery)
- Postoperative hospital stay(within 2 weeks after surgery)
- Postoperative bleeding incidence(within 2 weeks after surgery)
- Postoperative complication incidence(within 1 month after surgery)
- Quality of life(within 1 year after surgery)
- 2-year disease free survival and overall survival(2 years after surgery)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (1)
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