NCT07106502

Brief Summary

Hypothesis is that better training of medical students in the examination of boy's external genitalia could improve the diagnosis of testicular position anomalies. To this end, investigators already have created a model to train testicle palpation and recognition of testicular position anomalies. So investigator set up a monocentric randomized controlled trial in wich the medical students will be randomized into 2 groups : a control group receiging only book-based theoretical instruction on the examination of the external genitalia and testicular position anomalies, and a mannequin group receibing, in addition to this conventionnal instruction, simulation training on the mannequin Medical students will then attend a consultation with a child whose reason for coming to the hospital is a testicular positioning anomaly. Students clinical examination will be scored by the consulting senior, and the final diagnosis retained by the student will be compared with that retained by the consulting senior. The aim is to show that medical students who have trained on this new model are better, in terms of clinical examination and diagnostic, than students in the control group.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

cryptorchidismtesticular palpation

Outcome Measures

Primary Outcomes (1)

  • Rate of correct diagnoses

    The primary outcome will be the rate of correct diagnoses made by the medical students compared with the diagnosis made by the consultant surgeon.

    Baseline

Secondary Outcomes (1)

  • clinical examination score from 0 to 20

    Baseline

Study Arms (2)

Control group

NO INTERVENTION

mannequin simulation-based learning group

EXPERIMENTAL
Procedure: testicular palpation training on a mannequin

Interventions

Study of testicular palpation training on a mannequin on the ability to perform a testicular examination and diagnose testicular positioning abnormalities

mannequin simulation-based learning group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student who volunteers to take part in the study during their pediatric or pediatric surgery clerkship or at the simulation center

You may not qualify if:

  • student non in pediatric intership or non in pediatric surgery intership or non at the simulation center intership
  • Student with previous simulation training in the examination of the external genitalia of children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Study Officials

  • Louise RENOULT

    University Hospital of Angers

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 6, 2025

Record last verified: 2025-07