i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Subjective outcome
研究概览
简要总结
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
详细描述
The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.
The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.
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
- •Surgery for POP
- •SSLF with usage of i-Stitch device (& i-Stitch Loading Units)
- •Concomitant procedures are allowed
- •Women minimum 18 years old
- •Written informed consent for surgery
排除标准
- •infection (active or latent)
- •allergies to the materials used
- •benign or malignant changes
- •anticoagulation disorders
- •autoimmune connective tissue disorders
- •any uterus pathologies
结局指标
主要结局
Subjective outcome
时间窗: 3 months
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Subjective outcome
时间窗: 12 months
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
次要结局
- Quality of life (ICIQ-UI SF)(12 months)
- Postoperative complications(12 months)
- Anatomical outcome (POP-Q)(12 months)