Approach to Hiatal Hernia Repair Based on Collagen Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 主要终点
- Recurrence rate of hiatal hernia
研究概览
简要总结
Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.
详细描述
The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques.
Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery.
Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 20 years
- •Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
- •Performance of laparoscopic hiatal hernia repair
- •Informed Consent as documented by signature
排除标准
- •Cases of conversion to open surgery
- •Age < 20 years and > 80 years
- •History of oesophageal/gastric/duodenal surgery including vagotomy
结局指标
主要结局
Recurrence rate of hiatal hernia
时间窗: 36 months
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
次要结局
- Quality of life and satisfaction(36 months)
研究者
Grubnik Volodymyr
MD, Professor
Odessa National Medical University