Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results (TP-JET)

April 10, 2024 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Consultation at 12 months of trauma on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of permanent stoma
Time Frame: Consultation at 12 months of trauma on average
No long-term plan for restoration of digestive continuity
Consultation at 12 months of trauma on average
Rate of acontractile bladder
Time Frame: Consultation at 12 months of trauma on average
Self-catheterization
Consultation at 12 months of trauma on average
Rate of sexual dysfunction
Time Frame: Consultation at 12 months of trauma on average
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
Rate of impact on quality of life
Time Frame: Consultation at 12 months of trauma on average
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Thomas BARDOL, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-MTP_2022_09_202201170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Incontinence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe