Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 10:18 PM
Study NCT ID:
NCT02233569
Status:
TERMINATED
Last Update Posted:
2014-09-08
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Sponsor:
Polish Hernia Study Group
Organization:
Study Overview
Official Title:
COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.
Detailed Description:
None
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?: