Long Term Follow-up for Hypospadias

NCT ID: NCT04142632

Last Updated: 2025-01-06

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

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-17

Study Completion Date

2026-02-17

Brief Summary

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Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations.

In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term.

This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.

Detailed Description

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Conditions

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Hypospadias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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long term evaluation of hypospadias surgery

clinical and paraclinical examination

Intervention Type PROCEDURE

Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment

Interventions

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clinical and paraclinical examination

Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male patients
* with previous hypospadias surgery,
* Birthday before December the 31th 2009.
* The surgery was performed by one operator, with the following surgical technics: Koff, Onlay and Koyanagi.
* The patients are informed by an official surgery department letter, to assure they agree to participate.
* if the patient is still an infant, the parental agreement will be necessary.

Exclusion Criteria

* Patient deceased
* Non- agreement from the patient or his parents
* Language difficulties
Minimum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valeska BIDAULT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant

Locations

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Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valeska BIDAULT, MD

Role: CONTACT

04 27 86 92 12 ext. +33

Facility Contacts

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Valeska Bidault, MD

Role: primary

04 27 86 92 12 ext. +33

Other Identifiers

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2019-A02136-51

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0334

Identifier Type: -

Identifier Source: org_study_id

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