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

NCT ID: NCT06368284

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Perineum; Tear, Traumatic Anal Tear Anal Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas BARDOL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas BARDOL, MD

Role: CONTACT

04 67 33 90 69

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thomas BARDOL, MD

Role: primary

04 67 33 90 69

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-MTP_2022_09_202201170

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Complex Treatment of a Chronic Anal Fissure
NCT03855046 RECRUITING PHASE4