A Multicentre Prospective Study in Patients Undergoing Ventral Hernia Repair by Open Approach With Intraperitoneal Positioning Using Parietex™ Composite Ventral Patch - Panacea Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 10
- 主要终点
- Primary Hernia Recurrence Rate at 24 Month Follow-up.
研究概览
简要总结
The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.
详细描述
Prospective, multicenter, multinational non-comparative study.
Primary Endpoint: Primary hernia recurrence* rate at 24 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography.
Secondary Endpoints: Primary hernia recurrence* rate at 1, 6 and 12 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography.
(*Recurrence is defined as a clinically manifested bulge or a protrusion exacerbated by a Valsalva maneuver.)
Safety Parameters:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach
- •Signed informed consent form by the patient or the legally authorized representative
- •Intraoperative inclusion criteria :Size of the defect: ≤ 4 cm
排除标准
- •Emergency procedure
- •Current participation in other trials
- •History of previous hernia at the same location.
- •Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
- •Patient < 18 years
- •BMI > 35
- •ASA score ≥ 4
- •The investigator determined that the patient will not be able to comply with the required follow-up visits
结局指标
主要结局
Primary Hernia Recurrence Rate at 24 Month Follow-up.
时间窗: 24 month follow-up
The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.
次要结局
- Recurrence Rate at 1, 6 and 12 Month Follow-up(1, 6 and 12 month follow-up.)