NCT02328248Unknown2 期
Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
Xijing Hospital of Digestive Diseases0 个研究点目标入组 150 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 主要终点
- The incidence of complications in all case
研究概览
简要总结
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.
详细描述
observation indicator:
- incidence rate of complications,
- postoperative hospital stay
- readmission rate in 1st month after operation
- recurrence rate after operation
- hospitalization costs
- Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hiatal hernia
- •Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
- •randomly select patch agreed by patients and family members
排除标准
- •Poor general condition
- •severe organ dysfunction
- •No-tolerate anesthesia
- •No-suitable for operation
- •Emergency operation needed
- •Serious adverse events appeared during the operation
- •Sever intraperitoneal adhesion existed
- •glucocorticoid with long-term use
- •immunocompromised patients
- •spirit disease patients
- •automatically exit
- •women who pregnant
结局指标
主要结局
The incidence of complications in all case
时间窗: five years
次要结局
未报告次要终点
研究者
Xiaonan Liu
associate professor
Xijing Hospital of Digestive Diseases
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