Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455299
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2007-04-02
Brief Title:
LVHR Multicenter Study
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation
Detailed Description:
Patients are randomized to 4 groups non-absorbable suture fixation and hernia approximation double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation
Primary endpoint is recurrence Secondary endpoints are operating time adhesion score mode of entering abdominal cavity time to recovery pain durance seroma formation aesthetic result protrusion organ traumatization infection Endpoints are correlated to hernia size body mass index previous recurrence age concurrent illness Patients are followed 3 years after operation with clinical examination
300 patients are planned included in primary study A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion
Primary endpoint is recurrence Secondary endpoints are operating time adhesion score mode of entering abdominal cavity time to recovery pain durance seroma formation aesthetic result protrusion organ traumatization infection Endpoints are correlated to hernia size body mass index previous recurrence age concurrent illness Patients are followed 3 years after operation with clinical examination
300 patients are planned included in primary study A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion
Study Oversight
Has Oversight DMC:
None
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?:
None