NCT02345954Unknown不适用
Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Operation time
研究概览
简要总结
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus).
The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Symptomatic uterus prolapse (uterus < 300g)
- •Patient able to sign the informed consent and to fulfil the follow up visits
排除标准
- •Indication: Pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (>5 mm), abnormal PAP smear in the last 5 years, bleeding anomalies in premenopausal patients
- •General medical contraindications to a surgical operation
- •tumor/ malignant disease
- •bacterial infection at time of surgery
- •drug or medication abuse at time or just before surfer
- •Disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition)
- •Known hypersensitivity to the implanted materials
- •Immaturity, inability to answer/understand questions
- •Planned pregnancy
- •Participation to other studies (drugs or medical techniques) which could influence the results of this study
结局指标
主要结局
Operation time
时间窗: expected average of 150 minutes
Comparison of operation time in the 2 arms of the study
次要结局
- Intra- and postoperative complication rate(1 year)
- Duration of anaesthesia(expected average of 200 minutes)
- IUGA Pelvic Organ Prolapse Quantification (POP-Q)(8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention)
- Quality of Life(8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention)
- Patient satisfaction after surgery(At follow up 6 weeks, 6 months and 12 months after intervention)
- Bladder and bowel function, Prolapse symptoms, Sexuality(8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention)
研究者
Dimitri Sarlos
Chair Department of Gynecology
Kantonsspital Aarau
研究点 (2)
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