NCT00272922已完成不适用
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
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
- 否
入选标准
- •Age > 18 years
- •Documented symptomatic paraesophageal hernia
- •Ability to participate in follow-up evaluation
- •Has a telephone
- •Free of cognitive or speech impairment
排除标准
- •Patients requiring intra-operative conversion to an open procedure
- •Unable to close the crura primarily
- •Short esophagus that requires the surgeon to perform a lengthening procedure
- •Previous operation of the esphagus or stomach
- •Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
- •Intraoperative full-thickness perforation of the esophagus
- •Emergent operation for acute volvulus
- •Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or < 70% propagation of peristaltic waves in the distal esophagus
研究者
研究点 (2)
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