A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.
研究概览
简要总结
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.
The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
- •Have signed an Informed Consent Form (ICF).
排除标准
- •Underwent implantation of Sepramesh for any reason other than ventral hernia repair.
结局指标
主要结局
Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.
时间窗: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.
次要结局
- Complications in Subjects With Hernias Repaired With Sepramesh.(12 months or greater (average follow-up time of 3 years; range 13-65 months))
- Procedural Time for Sepramesh Placement.(Day 0)
- Recovery Time Associated With Hernias Repaired With Sepramesh.(12 months or greater (average follow-up time of 3 years; range 13-65 months))