NCT05069493

Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• GERD
• Hiatal Hernia
• Dysphagia, Esophageal
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	simple suturing	Hiatal hernia repair by simple suturing of the diaphragmatic
PROCEDURE	mesh	Hiatal hernia repair by tension-free mesh closure

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-03-30
• Completion: 2022-06-30
• First posted: 2021-10-06
• Last updated: 2022-10-18

Locations

1 site across 1 country: Sweden