Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 1:30 AM
Study NCT ID:
NCT04591860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
Sponsor:
Paracelsus Medical University
Organization:
Study Overview
Official Title:
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh
The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).
The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.
The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).
The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: