Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Recurrent hiatal hernia
研究概览
简要总结
10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
详细描述
One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.
This study is a long-term follow-up (>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients available at the time of follow-up
排除标准
- •Declined participation
结局指标
主要结局
Recurrent hiatal hernia
时间窗: 10 years
The incidence of radiologically verified recurrent hiatal hernia
次要结局
- Quality of Life, physical and mental score: SF-36(10 years)
- Proton pump inhibitor (PPI)(10 years)
- Dysphagia(10 years)
- Gastrointestinal symptom rating scale (GSRS)(10 years)
研究者
Lars Lundell
professor
Karolinska University Hospital
