Clinical trial NCT06368284: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
Official title: Observational Study of Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perineum; Tear, Traumatic
Anal Tear
Anal Incontinence
Keywords: Ano-perineal trauma
Ano-perineal injury
Personal watercraft
Jet-Ski
functional outcomes
peripheral neurogenic bladder
fecal incontinence
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of fecal incontinence
timeFrame: Consultation at 12 months of trauma on average
Secondary outcomes:
measure: Rate of permanent stoma
timeFrame: Consultation at 12 months of trauma on average
measure: Rate of acontractile bladder
timeFrame: Consultation at 12 months of trauma on average
measure: Rate of sexual dysfunction
timeFrame: Consultation at 12 months of trauma on average
measure: Rate of impact on quality of life
timeFrame: Consultation at 12 months of trauma on average
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Thomas BARDOL, MD
role: PRINCIPAL_INVESTIGATOR
References: