Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Required a Revision of the Index Surgery.
研究概览
简要总结
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
详细描述
Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure
Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH.
Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair.
Secondary Objectives
A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Who Required a Revision of the Index Surgery.
时间窗: 6-18 months post index procedure
Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
次要结局
- Medication Use(6-18 months post index procedure)
- Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)(6-18 months post index procedure)