NCT03025932Enrolling By Invitation不适用
Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
Prof Urs Zingg0 个研究点目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 主要终点
- Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
研究概览
简要总结
Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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 older than 18 years
- •Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
- •Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication
- •Informed Consent as documented by signature (Appendix: Informed Consent Form)
排除标准
- •Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
- •Performance of anterior fundoplication without mesh
- •Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study
结局指标
主要结局
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
时间窗: minimum 1 year after surgery
To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography
次要结局
- Peri- and postoperative morbidity / mortality(minimum 1 year after surgery)
- Quality of life by GIQLI(minimum 1 year after surgery)
- Clinical outcome(minimum 1 year after surgery)
研究者
Prof Urs Zingg
PD Dr. med.
Spital Limmattal Schlieren
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