Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 16
- 主要终点
- Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
研究概览
简要总结
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.
详细描述
Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
- •informed and not opposed to the use of her data
排除标准
- •Opposed to the use of her data
结局指标
主要结局
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
时间窗: up to 30 days after surgery
Perioperative morbidity
次要结局
- Number of Patients With Postoperative Urinary Signs(up to 4 years after surgery)
- Number of Patients With Late Complications(up to 4 years after surgery)
- Number of Patients With Postoperative Active Sexuality(up to 4 years after surgery)
- Postoperative Score at Numeric Pain Rating Scale(up to 48 hours after surgery)
- Number of Patients With Early Complications(up to 30 days after surgery)
- Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery(preoperative, within 48 hours before surgery)
- Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery(up to 4 years after surgery)
- Number of Patients With Preoperative Urinary Signs(within 4 weeks before surgery)
- Number of Patients With Preoperative Digestive Signs(within 4 weeks before surgery)
- Number of Patients With Postoperative Digestive Signs(up to 4 years after surgery)
- Number of Patients With Preoperative Active Sexuality(within 4 weeks before surgery)
- Number of Patients With Preoperative Dyspareunia(within 4 weeks before surgery)
- Number of Patients With Postoperative Dyspareunia(up to 4 years after surgery)
- Preoperative Score at Numeric Pain Rating Scale(Within 48 hours before surgery)