Anal Incontinence Clinical Trial
— TP-JETOfficial title:
Observational Study of Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023. Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023 - managed and followed in France Exclusion Criteria: - <18 years old |
Country | Name | City | State |
---|---|---|---|
France | Chu Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of fecal incontinence | Defined by the fecal incontinence Wexner Score >10 (Score from 0 to 20, the higher the score, the greater the incontinence.) or by ano-rectal manometry. | Consultation at 12 months of trauma on average | |
Secondary | Rate of permanent stoma | No long-term plan for restoration of digestive continuity | Consultation at 12 months of trauma on average | |
Secondary | Rate of acontractile bladder | Self-catheterization | Consultation at 12 months of trauma on average | |
Secondary | Rate of sexual dysfunction | defined as Female Sexual Function Index (FSFI) score <26,55 (Score from 2 to 36, the lower the score, the greater the dysfunction.) | Consultation at 12 months of trauma on average | |
Secondary | Rate of impact on quality of life | rated by 12-Item Short Form Survey (SF-12) (the higher the score, the greater the quality of life) | Consultation at 12 months of trauma on average |
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