Fecal Incontinence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESphinkeeperTM
The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile)
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna * Ability and willingness to understand and comply with study interventions and restrictions. * Voluntarily signed informed consent after full explanation of the study to the participant
Exclusion criteria
* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives * Inability to communicate well with the investigator due to language problems or reduced mental development * Inability or unwillingness to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration of prostheses | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of migration of the prostheses in functionality | 6 months | 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. |
| Psychological and physical well-being | 6 months | 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) |
| Morphology of the anal sphincter after operation | 6 months | Differences of the morphology before and after the operation got examined by endoanal ultrasound. |
Countries
Austria
Outcome results
None listed