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临床试验/NCT05069493
NCT05069493已完成不适用

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

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2021年9月15日最近更新:
适应症

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

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

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Lundell

professor

Karolinska University Hospital

研究点 (1)

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