Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT05662735
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
Sponsor:
Rijnstate Hospital
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
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:
PRIME LTFU
Brief Summary:
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: