Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- RATE AND TYPE OF REINTERVENTION
研究概览
简要总结
An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).
Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center. Data from consultation visits and surgery data will be collected and filled in the observation books.
The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The inclusion criteria for participation in the study are as follows:
- •Patient who underwent surgery to place the Sacromesh® medical device for a prolapse cure, between 2009 and 2018 in one of the investigation centres participating in the study.
- •Patient who has read the information note and has not formulated an -opposition.
- •Adult patient with full mental capacity/capability
排除标准
- •Patient under guardianship or curatorship
- •Patient hospitalized at time of inclusion
- •Patient with an adjacent pathology that may strongly interfere with her quality of life and VAS score.
- •Patients with mental psychological pathology
结局指标
主要结局
RATE AND TYPE OF REINTERVENTION
时间窗: 2020 - 2023
safety assessment of Sacromesh® implan through the documentation, within the French healthcare context, of the rate and type of re-interventions after Sacromesh® implantation. Collection and documentation of the nature and frequency of reinterventions after placement of the Sacromesh® device, including causes and nature of eventual explants, be it total or partial. The rate of re intervention will be calculated using Yes/No answer to POP recurrence question in the CRF. Yes answer to the question will be considered as a re intervention. In case of any POP recurrence investigator was asked to fill an adverse event form to describe the re intervention. Type of re intervention will be derived from AE form into a two classes categorical variable taking either 'De novo prolapse (recurrence, vaginal extrusion)' or 'Other' value. Both rate of re intervention and type of re intervention will be described as qualitative variables.
次要结局
- evaluation the tolerance of the Sacromesh® implant Rate and type of postoperative complications(2020 - 2023)
- evaluation the tolerance of the Sacromesh® implant qol(2020 - 2023)
- evaluation the tolerance of the Sacromesh® implant postoperative pain(2020 - 2023)