NCT01679548已完成不适用
Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- postoperative hospital stay
研究概览
简要总结
To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease
详细描述
This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.
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 assisted vaginal hysterectomy due to following gynecologic disease
- •uterine leiomyoma
- •uterine adenomyosis
- •Endometrial hyperplasia
- •cervical intraepithelial neoplasia including carcinoma in situ
- •Dysfunctional uterine bleeding
- •Other benign gynecologic disease requiring hysterectomy
- •American Society of Anesthesiologists Physical Status classification I-II
- •Patient who have signed an written informed consent
排除标准
- •Uncontrolled medical disease
- •Active infectious disease
- •Previous pelvic radiation therapy
- •Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
- •Patient who undergoes subtotal hysterectomy
- •Patient who have other pain source excluding gynecologic disease
- •Pregnancy and lactating woman
研究组 & 干预措施
Single-port LAVH group
Experimental
single-port laparoscopic assisted vaginal hysterectomy
干预措施: Single-port LAVH (Procedure)
Three-port LAVH group
Active Comparator
three-port laparoscopic assisted vaginal hysterectomy
干预措施: Three-port LAVH (Procedure)
结局指标
主要结局
postoperative hospital stay
时间窗: within 1 week after surgery
The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.
次要结局
- intra and postoperative complication(within 1 months after surgery)
- postoperative analgesics requirement(within 1 week after surgery)
- operating time(1 day (immediately ater surgery))
- postoperative pain(within 1 week after surgery)
- Transfusion requirement and amount(within 1 week after surgery)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (1)
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