Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 3:59 PM
Study NCT ID:
NCT02932033
Status:
UNKNOWN
Last Update Posted:
2016-11-04
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia
Sponsor:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Organization:
Study Overview
Official Title:
Randomized Control Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP (Total Extraperitoneal) Repair for Groin Hernias
Status:
UNKNOWN
Status Verified Date:
2016-11
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:
TEP
Brief Summary:
This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.
Detailed Description:
consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.
Study Oversight
Has Oversight DMC:
True
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?: