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Clinical Trial Summary

10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05069493
Study type Observational
Source Karolinska University Hospital
Contact
Status Enrolling by invitation
Phase
Start date September 15, 2021
Completion date March 30, 2022

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