Long-term follow-up for boys with hypospadias
Long Term Follow-up for Hypospadias. Hypospadias KOK
Hospices Civils de Lyon · NCT04142632
This study looks at how well different surgical methods for fixing hypospadias work in boys after they reach puberty.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years and up |
| Sex | Male |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT04142632 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term outcomes of male patients who have undergone surgical correction for hypospadias. It focuses on assessing physical and paraclinical examinations after puberty to determine the effectiveness of three commonly used surgical techniques: Koff, Onlay, and Koyanagi. The study will include male patients who had surgery performed by a single operator and will require informed consent from participants or their parents if they are still infants.
Who should consider this trial
Good fit: Ideal candidates are male patients who had hypospadias surgery before December 31, 2009, performed by a specific surgeon using designated techniques.
Not a fit: Patients who are deceased, do not agree to participate, or have language difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of surgical techniques for hypospadias, improving future treatment approaches.
How similar studies have performed: While there may be studies on short-term outcomes of hypospadias surgery, this long-term follow-up approach is relatively novel and aims to fill a gap in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron
- Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant — Bron, France (RECRUITING)
Study contacts
- Principal investigator: Valeska BIDAULT, MD — Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
- Study coordinator: Valeska BIDAULT, MD
- Email: valeska.bidault@chu-lyon.fr
- Phone: 04 27 86 92 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypospadias