NCT04669756已完成不适用
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- prevalence of postoperative ovarian adhesions
研究概览
简要总结
prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal
- •wants to participate
- •removal of endometriosis of the pelvic side wall or ovary
排除标准
- •postmenopausal
- •cannot give informed consent
- •no endometriosis during Operation
- •no Opening of pelvic side wall or ovary during the Operation
- •breast feeding
研究组 & 干预措施
A
Experimental
ovariopexy for 2 days
干预措施: ovariopexy (Procedure)
B
Experimental
ovariopexy for 4 days
干预措施: ovariopexy (Procedure)
C
Experimental
ovariopexy for 6 days
干预措施: ovariopexy (Procedure)
D
Placebo Comparator
Placebo Operation for 2 days
干预措施: placebo operation (Procedure)
结局指标
主要结局
prevalence of postoperative ovarian adhesions
时间窗: 3 months after operation
prevalence of postoperative ovarian adhesions
次要结局
- postoperative pain(daily during postoperative hospitalisation and at follow up visit after 3 months)
- postoperative infectious complications(up to 3 months after operation)
- AMH(at follow up visit after 3 months)
研究者
Dr. med. Sebastian Daniel Schäfer
Head of Gynecology
University Hospital Muenster
研究点 (1)
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