Trials / Completed
CompletedNCT04664868
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (actual)
- Sponsor
- Medical University of Vienna · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sphinkeeper™ | Sphinkeeper™ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-11-01
- Completion
- 2020-07-01
- First posted
- 2020-12-11
- Last updated
- 2020-12-11
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04664868. Inclusion in this directory is not an endorsement.