The Use of Reconstructive Surgery for Sexually Mutilated Women at the University Hospitals of Strasbourg (Repair-SM)

December 13, 2023 updated by: University Hospital, Strasbourg, France

Use of Reconstructive Surgery for Women Consulting in Sexology at the University Hospitals of Strasbourg for Sexual Mutilation

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

29

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

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Jeanine OHL, MD
        • Contact:
        • Principal Investigator:
          • Virginie TEISSEYRE, MD

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

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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
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.
Time Frame: Through study completion, an average of 6 months
This assessment is made via a questionnaire of nine questions relating to their future.
Through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

November 24, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Estimated)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8724

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.

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