Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results

Anal Incontinence Clinical Trial

— TP-JET  

Official title:

Observational Study of Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368284
• Other study ID #: IRB-MTP_2022_09_202201170
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Montpellier
• Contact: Thomas BARDOL, MD
• Phone: 04 67 33 90 69
• Email: t-bardol[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Ano-perineal injuries and their mechanisms resulting from personal watercraft (PWC)/Jet-Ski accidents are poorly understood and may lead to long-term functional repercussions, previously unmentioned in studies. These accidents are in France but, mostly, concerned young women, back-seated on the PWC without any specific protection. Therefore, the research team conducted a French multicentric cohort study that retrospectively included patients who experienced ano-perineal trauma following a personal watercraft/Jet-Ski accident and were treated in France. Data on pre-hospital management, pre-operative work-up, surgical management (including surgical techniques), short-term and long-term complications (routinely used functional scores) were collected through the analysis of personal medical records. Several patients had sphincteric, rectal, vaginal, or combined injuries, sometimes requiring the establishment of a stoma. the investigators subsequently evaluated the rate of fecal incontinence (evaluated by anorectal manometry or Wexner score), urological (USP score), and sexual outcomes (FSFI). Quality of life was also assessed using the SF12 score.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

Procedure:
• Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident
Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023, managed and followed up in France

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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