Perineum; Tear, TraumaticTP-JETNCT06368284
Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
An observational study of Perineum; Tear, Traumatic and Anal Tear, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Perineum; Tear, Traumatic, Anal Tear, Anal Incontinence
- What is being tested?
- Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023
- managed and followed in France
Who cannot join
- <18 years old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Montpellier
Montpellier, 34295
Thomas BARDOL, MD, 04 67 33 90 69, t-bardol@chu-montpellier.fr
About this study
Official 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.
Read the 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.
- Conditions
- Perineum; Tear, Traumatic, Anal Tear, Anal Incontinence
- Being tested
- Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident
- Keywords
- Ano-perineal trauma, Ano-perineal injury, Personal watercraft, Jet-Ski, functional outcomes, peripheral neurogenic bladder, fecal incontinence
- Medical subject headings
- Lacerations, Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accidentProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Consultation at 12 months of trauma on average
Secondary outcomes (4)
Rate of permanent stoma
No long-term plan for restoration of digestive continuity
Measured: Consultation at 12 months of trauma on average
Rate of acontractile bladder
Self-catheterization
Measured: Consultation at 12 months of trauma on average
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.)
Measured: Consultation at 12 months of trauma on average
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)
Measured: Consultation at 12 months of trauma on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Apr 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineum; Tear, TraumaticStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas BARDOL, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368284
- Sponsor's protocol ID
- IRB-MTP_2022_09_202201170
- Acronym
- TP-JET
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
- ClinicalTrials.gov ID
- NCT06368284
- Acronym / sponsor ID
- TP-JET / IRB-MTP_2022_09_202201170
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023
- managed and followed in France
Key exclusion criteria (1 listed)
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accidentPatients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023, managed and followed up in France | Procedure or surgery | – |
Primary outcome
Rate of fecal incontinence
Time frame: Consultation at 12 months of trauma on average
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.
4 secondary outcomes
Rate of permanent stoma
Time frame: Consultation at 12 months of trauma on average
Rate of acontractile bladder
Time frame: Consultation at 12 months of trauma on average
Rate of sexual dysfunction
Time frame: Consultation at 12 months of trauma on average
Rate of impact on quality of life
Time frame: Consultation at 12 months of trauma on average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas BARDOL, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineum; Tear, Traumatic and Anal Tear, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas BARDOL, MD (04 67 33 90 69, t-bardol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fecal incontinence (time frame: Consultation at 12 months of trauma on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.