Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664868
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-11-30
Brief Title:
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Status:
COMPLETED
Status Verified Date:
2020-12
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:
Patients aged 18 - 90 years undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study Primary endpoints is the functional outcome as well as movement migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination
Detailed Description:
The Sphinkeeper implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy Therefore we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI
Patients with FI who met the inclusion criteria were enrolled to our study and received Sphinkeeper implantation Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery In the routine check-up patients received endoanal ultrasound and anorectal manometry
Patients with FI who met the inclusion criteria were enrolled to our study and received Sphinkeeper implantation Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery In the routine check-up patients received endoanal ultrasound and anorectal manometry
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