Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372190
Status:
COMPLETED
Last Update Posted:
2017-07-03
First Post:
2006-09-05
Brief Title:
Performance of Tension Free Vaginal Mesh Prolift Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh Prolift Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Pelvic organ prolapse is a common problem A lot of women have surgery for prolapse The recurrence rate op pelvic organ prolapse after surgical treatment is high Placement of a mesh aims at reducing the recurrence rate but mesh implants can cause complications
This study is designed to determine the effectiveness of one type of mesh tensionfree vaginal mesh Prolift compared with the standard prolapse surgery A secondary objective is to track the complications of both procedures
This study is designed to determine the effectiveness of one type of mesh tensionfree vaginal mesh Prolift compared with the standard prolapse surgery A secondary objective is to track the complications of both procedures
Detailed Description:
Patients with recurrent prolapse after surgery can participate in this study A total of 194 women will be included At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh Evaluation will take place during surgery at the postoperative visit after six weeks and after six months and twelve months Quality of life degree of vaginal prolapse subjective effectiveness safety and incidence of complications will be evaluated
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years This study was completed in december 2015
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years This study was completed in december 2015
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