Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 3:07 PM
Study NCT ID:
NCT05069493
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2021-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Sponsor:
Karolinska University Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
This study is a long-term follow-up (\>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: