PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
研究概览
简要总结
The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years old
- •Genital anterior prolapse requiring surgical correction and with stage III or IV in the classification of Pelvic Organ Prolapse - Quantification or POP-Q
- •Ability to understand the information and to sign a consent form
- •Patients wishing an intervention because of the inconvenience caused by the prolapse.
排除标准
- •* Prolapse stage \ 8%)
- •* Treatment modifying the immune response (immuno-modulators), current or stopped for less than one month
- •* Inability to understand the information and to sign a consent
- •* A person not subject to social security, deprived of freedom, or under legal guardian
研究组 & 干预措施
1
Traditional surgical method without prosthesis
干预措施: Traditional surgery (Procedure)
2
Surgical method with Perigee prosthesis
干预措施: Perigee® prosthesis (Device)
结局指标
主要结局
Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery
时间窗: 12 months
次要结局
- Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence(at 3,12, 24 months)
- Pain after surgery(24 months)
- Duration of intervention(24 months)
- Correction of prolapse 2 years after surgery(24 months)