NCT01683877已完成不适用
PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Hemostasis time
研究概览
简要总结
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women
- •Patients who is planned to undergo laparoscopic ovarian cystectomy
- •American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2
- •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
- •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 or nursing
- •Patients who is receiving or requires hormone replacement therapy after surgery
- •Patients who is undergoing hysterectomy at this time
- •Patients who is undergoing unilateral or bilateral oophorectomy
- •Previous history of ovarian cystectomy or oophorectomy
- •Patients with contraindications to surgery
- •Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Patient compliance and geographic proximity that do not allow adequate follow-up.
- •Hormone therapy within 3 months before surgery
结局指标
主要结局
Hemostasis time
时间窗: Immediately after operation
次要结局
- Intraoperative blood loss(During surgery)
- Operative time(1 day (Immediately after surgery))
- Postoperative drainage duration(within 1 week after surgery)
- Ovarian function after surgery(within 6 months after surgery)
- Length of postoperative stay(within 1 month after surgery)
- Postoperative complications(within 1 months after surgery)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (2)
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