Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450671
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2007-03-20
Brief Title:
Treatment of Perirectal Fistula With Cutting Seton vs Collagen Plug
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Seton Placement vs Surgisis Anal Fistula Plug Insertion for Perirectal Fistula A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2017-03
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 purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method
Detailed Description:
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate fistulotomy or delayed seton transsection of the sphincter muscle possibly resulting in fecal incontinence take a long time to heal andor are associated with significant failure rates ex fibrin glue
Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle avoid and minimize the risk of fecal incontinence and decrease the time to fistula healing Exciting initial reports have confirmed the collagen plugs utility in treating perirectal fistulae but a systematic scientific comparison is needed to validate the new less invasive plug method
The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method
Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle avoid and minimize the risk of fecal incontinence and decrease the time to fistula healing Exciting initial reports have confirmed the collagen plugs utility in treating perirectal fistulae but a systematic scientific comparison is needed to validate the new less invasive plug method
The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS-06-00342 | OTHER | USC IRB | None |