Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT01026935
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2009-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.
Status:
COMPLETED
Status Verified Date:
2009-12
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:
For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: