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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.
The Sphinkeeperâ„¢ 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 Sphinkeeperâ„¢ surgery in patients with refractory FI.
Patients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeperâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphinkeeperâ„¢ | Procedure | Sphinkeeperâ„¢ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove. |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal incontinence assessment | Episodes and number of faecal incomtinence and stool form with faecal incontinence were assessed using the Vaizey incontinence score (range 0-22, higher numbers mean severe incontinence forms) | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological und physical well-being | The Psychological und physical well-being before and after implantation of Sphinkeeper was assessed using the SF12 standardized questionnaire (range 0-100; higher scores= Better quality of life) | six months |
| Migration of Sphinkeeper prostheses |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates for sphinkeeper operations due to fecal incontinence will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Riss, Prof.MD | Medical University of Vienna, Head of Pelvic Floor surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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The Migration of Sphinkeeper prostheses were analyzed using endoanal ultrasound one and six months after implantation. The prostheses will be categorized by their position in relation to the anal canal axis. (Grade of rotation to the anal canal axis) |
| six months |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |