A Prospective Registry of Patients With Congenital Penile Anomalies

NCT04755803 | Completed

• 1 other identifier: 2008-057-1147
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective registry and biobank in pediatric patients with congenital penile anomalies

Conditions

Concealed Penis; Hypospadias; Phimosis; Chordee

Outcome Measures

Primary Outcomes (1)

• Dartos Fascia (Penile Tissue) sample collection

  Collection of biological samples from pediatric patients who have been registered onto the prospective registry.

  Procedure (At the time of penoplasty)

Interventions

Penoplasty PROCEDURE

Modified penoplasty technique: 1. Degloved the penile skin and excise the inner prepuce. 2. Advanced penoscrotal skin to cover penile shaft 3. Fixed the penis base and reconstructed the penoscrotal angle

Eligibility Criteria

• Age: 0 Months - 18 Years
• Gender Eligibility Details: This registry is gender-specific and only males with congenital penile anomalies and receiving penoplasty at the institution are allowed to be enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male patients between the ages of 0 to 18 years with congenital penile anomalies and receiving penoplasty at the institution.

You may qualify if:

• Those with congenital penile anomalies (e.g. hypospadias, chordee, webbed penis) and receiving penoplasty at the institution.
• Those who understand the registry's content and are signed and dated by the patient (or the patient's legal guardian or representative).

You may not qualify if:

• Those who are unwilling to participate and do not sign the informed consent.
• Unable to read or understand Korean.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dartos Fascia is commonly known as subcutaneous tissue of the penis. It is located under the foreskin and superficially located on the outer external spermatic fascia of the scrotum and the axis of the penis. The primary role of dartos fascia is the mobility of the foreskin in the basal tissue and the blood supply from the external sinus vessels. Furthermore, it promotes heat loss and cools down the testicles.

MeSH Terms

Conditions

Hypospadias; Phimosis

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 16, 2021
• Study Start: July 10, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)