Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mesh erosion
研究概览
简要总结
Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Study design: Randomized controlled trial
Intervention:
Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy
详细描述
Uterovaginal prolapse is a common disease. Sacrocolpopexy is essentially invented to manage prolapse of the vault following hysterectomy. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. The main drawback of sacrocolpopexy is the risk of mesh erosion. The incidence of mesh erosion is 0-5% at follow up of 1 year and 0.5% at follow up of 7 years. After total hysterectomy, the mesh is sutured to the vaginal wall using non-absorbable sutures. Sutures that span the whole thickness of vaginal and involve the vaginal skin was considered the probable factor that result in mesh erosion. After subtotal hysterectomy, the mesh is fixed to the anterior and the posterior cervical surfaces. The cervix has thick wall and the risk associated with "deep" stiches does not exist.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Patients and methods
Study design:
Randomized controlled trial
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double (Participant, Investigator) closed envelop will be used for randomization. The patient and the investigator will be blinded.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse
排除标准
- •women age less than 40
- •desire to retain the uterus
- •women who are unfit for lengthy surgery
结局指标
主要结局
Mesh erosion
时间窗: 12 months or more
Mesh exposure through the lumen of the vagina, bladder, or rectum
次要结局
- recurrence(12 months or more)
研究者
Mohammad Abdel-Rahman Mohammad Ahmed
Doctor
South Valley University