NCT06183463

Brief Summary

Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. This custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications. Every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds. In recent years, a surgical repair technique has been created by a French urologist, Professor Foldès. This technique allows clitoral reconstruction. Sensory reacquisition after this intervention may take a few months, but the functional results are quite good. There is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. The investigators then questioned the decision of these patients and their future.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Keywords

Sexual mutilation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the future of patients who consulted sexology for sexual mutilation between 2011 and 2021 at the HUS, whether or not they opted for reconstructive surgery.

    This assessment is made via a questionnaire of nine questions relating to their future.

    Through study completion, an average of 6 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult woman (≥18 years old) having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.

You may qualify if:

  • Adult woman (≥18 years old)
  • having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
  • having had clitoral repair surgery at the HUS between 01/01/2011 and 12/31/2021
  • not objecting, after information, to the reuse of their data for the purposes of this research

You may not qualify if:

  • Woman who expressed her opposition to participating in the study
  • impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
  • Woman under judicial protection or under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Sexual Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 27, 2023

Study Start

November 24, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations