The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Anatomic hiatal hernia recurrence rate
研究概览
简要总结
The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented diagnosis of gastroesophageal reflux disease
- •Adults aged 18 years or older
- •English speaking
- •Subject is planned to undergo surgery for reflux disease
排除标准
- •Physician deems the subject is unable to complete the study due to documented dementia.
- •Subject is undergoing emergent surgery.
- •Pregnancy
- •Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate
研究组 & 干预措施
Biosynthetic Mesh
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects.
干预措施: Biosynthetic Mesh (Device)
Biosynthetic Mesh
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects.
干预措施: Hiatal Hernia Repair (Procedure)
No Mesh
The non-mesh group will undergo repair with permanent suture only.
干预措施: Hiatal Hernia Repair (Procedure)
结局指标
主要结局
Anatomic hiatal hernia recurrence rate
时间窗: 1 year
次要结局
- Anatomic Hiatal Hernia Recurrence rate(5 years)
- Reflux Symptoms(5 years postoperatively)
- Number of subjects requiring reoperation(30 days following surgery)
- Dysphagia Symptoms(5 years postoperatively)
- Number of subjects requiring 30 day readmission(30 days following surgery)
- Number of subjects developing postoperative Infection(30 days following surgery)