Ambulatory Surgery for Urogenital Prolapse : a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 主要终点
- Success rate of ambulatory surgery in patient operated for urogenital prolapse
研究概览
简要总结
Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.
Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.
This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.
A randomized control study will follow PCAP study.
详细描述
The prolapse surgery will be performed in 13% of women. Improved surgical and anesthetic techniques available makes this surgery to ambulatory care, while the latter is only slightly conducted in France.
Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.
Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.
This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.
A randomized control study will follow PCAP study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Age > 18 years
- •Planned POP surgery
- •Valid social insurance
- •French spoken and written
- •Informed consent signed
- •No exclusion criteria
排除标准
- •Refuse participation to study
- •Pregnant or lactating woman
- •Vulnerable people (Article L 1121-6 of the french code of public health)
- •Major subject to legal protection or unable to consent (Article 1121-8 of the french code of public health )
- •Participation in another protocol for less than 3 months
- •Patient not presenting all the inclusion criteria.
结局指标
主要结局
Success rate of ambulatory surgery in patient operated for urogenital prolapse
时间窗: After the 2 years of recruitment
Success rate = (number of patients with period of hospitalization \< 12 hours)/ (number of patients operated for prolapsus)
次要结局
未报告次要终点