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32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.
The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal incontinence, which includes up to ten self-expandable prostheses. These get implanted into the intersphincteric space and due to constriction of the anal canal and better contractibility continence should be improved. Because this is a new technique, there is only limited data about its clinical efficacy.
In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery. Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure measurement and endoanal ultrasound to determine the position of the prostheses.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SphinkeeperTM | Procedure | The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile) |
| Measure | Description | Time Frame |
|---|---|---|
| Migration of prostheses | The migration got analysed by using endoanal ultrasound one, two, three and six months after surgery. The prostheses will be categorized by their position in relation to the anal canal axis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of migration of the prostheses in functionality | Episodes of fecal incontinence and bowel habits were assessed using the Vaizey incontinence score (range 0-22, higher number means severe incontinence). It gets explored if there is a relation between migration of prostheses and worsening of incontinence. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates for sphinkeeper operation 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 |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Psychological and physical well-being |
The psychological and physical well-being before and after operation was assessed using the SF-12 standardized questionnaire. (range 0-100; higher scores= Better quality of life) |
| 6 months |
| Morphology of the anal sphincter after operation | Differences of the morphology before and after the operation got examined by endoanal ultrasound. | 6 months |