NCT01679509Unknown不适用
Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- postoperative hospital stay
研究概览
简要总结
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease
- •Benign teratoma
- •Endometrioma
- •Mucinous cystadenoma
- •Serous cystadenoma
- •Benign Brenner tumor
- •Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
- •paratubal cyst, parovarian cyst
- •Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
- •Other benign adnexal disease requiring surgery
- •American Society of Anesthesiologist Physical Status classification I-II.
- •Patient who have signed written informed consent
排除标准
- •Uncontrolled medical disease
- •Active infectious disease
- •Previous pelvic radiation therapy
- •Patient who requires further procedure excluding adnexal surgery
- •Patient who has other pain source excluding adnexal disease
- •Pregnant and lactating woman
研究组 & 干预措施
Single-port surgery group
Experimental
Single-port laparoscopic adnexal surgery
干预措施: Single-port laparoscopic adnexal surgery (Procedure)
Three-port surgery group
Active Comparator
Three-port laparoscopic adnexal surgery
干预措施: Three-port laparoscopic adnexal surgery (Procedure)
结局指标
主要结局
postoperative hospital stay
时间窗: within 1 week after surgery
次要结局
- postoperative pain(within 1 week after surgery)
- postoperative analgesics requirement(within 1 week after surgery)
- quality of life(within 6 months aftr surgery)
- surgical stress response(within 2 days after surgery)
- operating time(immediately ater surgery)
- transfusion requirement and amount(within 1 week after surgery)
- postoperative complication(within 1 months after surgery)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (1)
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