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

NCT06368284 | Recruiting

• 1 other identifier: IRB-MTP_2022_09_202201170
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of permanent stoma

  Consultation at 12 months of trauma on average

• Rate of acontractile bladder

  Consultation at 12 months of trauma on average

• Rate of sexual dysfunction

  Consultation at 12 months of trauma on average

• Rate of impact on quality of life

  Consultation at 12 months of trauma on average

Interventions

Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023
• managed and followed in France

You may not qualify if:

• \<18 years old

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Lacerations; Encopresis; Fecal Incontinence

Condition Hierarchy (Ancestors)

Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Thomas BARDOL, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas BARDOL, MD

CONTACT

04 67 33 90 69; t-bardol@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)