Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
研究概览
简要总结
This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.
详细描述
Genital prolapse is a very common functional pathology that affects 30% of women. The functional impact of prolapse is highly variable and may lead patients to consider surgery. Surgery for laparoscopic genital prolapse (laparoscopy) is a common practice. The placement of prostheses on the anterior and posterior walls of the vagina is sort of "estimated", performed without any quality control . This technique is associated with a high rate of patient satisfaction (90% satisfaction), but a risk of anatomical recurrence in 20-30% of cases and a risk of reoperation for relapse in 3% of cases. It is likely that the lower the intervesico-vaginal prosthesis, the lower the risk of cystocele relapse is important.The postoperative ultrasound visualization of prostheses placed in promontofixation is possible: they appear hyperechoic. In particular, in anterior, where a prosthesis is placed between the vagina and the bladder, it is possible to verify that this prosthesis supports the entire bladder base.Thus, it may be possible to check the correct position of the prostheses intraoperatively. If studies were conducted postoperatively, to the best of our knowledge, no study has been conducted on the value of an intraoperative ultrasound control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult women (>18 years-old)
- •patient who undergo laparoscopic sacral copopexy/hysteropexy
- •Affiliation to a public health insurance system
- •Written and informed consent given by the patient
排除标准
- •Pregnancy, breast-feading
- •woan involved in an interventional research
- •Patient under tutorship or curatorship
- •Pregnancy and breast feeding
研究组 & 干预措施
Intraoperative ultrasound
An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.
干预措施: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) (Diagnostic Test)
结局指标
主要结局
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
时间窗: at two months (± 1 month) of follow-up
Comparaison of intraoperative measurement to postoperative measurement
次要结局
- Stage of prolapse(until 2 months post-operative)
- Evaluate the symptoms with the PFDI-20 questionnaire(during 2 months post-operative)
- Evaluate patient satisfaction with the PGI-I questionnaire (1-7)(until 2 months post-operative)
- Evaluate the symptoms with the PFIQ-7 questionnaire(during 2 months post-operative)