Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Recurrence Rate
研究概览
简要总结
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data.
Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Diagnosis of type 3 or 4 hiatal hernia (8)
- •Subject is able to give informed consent
- •Adults at least 18 years of age
排除标准
- •Currently pregnant
- •Prior hiatal hernia repair
- •Prior gastric surgery
- •Prior foregut surgery
- •Known esophageal dysfunction or dysmotility
- •Cirrhosis or ascites
- •Known malignancy
- •Known allergy to biologic mesh
- •Known allergy to barium or other contrast material used in UGI
- •Religious objection to animal implant
- •Cognitive impairment
- •Prisoners
结局指标
主要结局
Recurrence Rate
时间窗: 6 months post surgery
Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.
次要结局
- Quality of Life Using GERD-HRQL Scale(pre-operative and 3 month and 6 month post surgery)