Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01612195
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2012-06-02
Brief Title:
Success Rate Continence and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Success Rate Continence and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals The course of abscess-fistula disease as well as its treatment modalities may affect anal continence The present cohort study investigates the results of anal fistula plug surgery In particular this study focus on the impact of anal fistula plug surgery on fistula healing quality of life and anal continence Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons
Detailed Description:
Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals The clinical course of abscess-fistula disease as well as its treatment modalities may affect anal continence Anal fistula plug surgery is an Health Canada and FDA approved surgical treatment that has demonstrated promising results in terms of fistula healing and minimal patients burden The present cohort study prospectively investigates the results of anal fistula plug surgery performed in teaching hospitals affiliated to the University of Toronto In particular this study focus on the impact of anal fistula plug surgery on health-related quality of life and its 2 major determinants anal continence and fistula healing Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons Quality of life and anal continence will be measured with the validated Short Form-36 Health Survey SF-36 v2 and Fecal Incontinence Score Index FISI questionnaires respectively It is expected that the present study will provide objective information on the results and generalizability of anal fistula surgery as well as on its impact on health-related quality of life and anal continence
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