Clinical trial NCT03295175: Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis
Official title: Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congenital Urogenital Anomaly
Keywords: Congenital Abnormalities
Hypospadias
Congenital megaprepuce
Histology
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 0
Sex: MALE
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.

Brief summary: Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. A redundant and enlarged foreskin is the main feature of this entity.This congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis.

Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. The investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. With the present study the investigators intended to answer these questions and to open paths for future research in this area.

Detailed description: After informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. The urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. Same procedure will be performed with the controls and hypospadias group. Only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.

Eligibility criteria: Inclusion Criteria:

* Male patients scheduled for correction of congenital megaprepuce
* Male patients scheduled for correction of hypospadias
* Male patients scheduled for circumcision for non-medical reasons.

Exclusion Criteria:

* Patients with a history of hypospadias correction.

Primary outcomes:
measure: Differences in the distribution of the smooth Muscle In Dartos
timeFrame: 1 year
measure: Describe the pattern of smooth muscle in patients with megaprepuce
timeFrame: 1 year
Secondary outcomes:
measure: Describe the pattern of smooth muscle in patients with hypospadias
timeFrame: 1 year
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Luis Gabriel Villarraga
Study officials:
affiliation: H
name: Jose N Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz E, Vagni R, Apostolo C, Moldes J, Rodriguez H, Ormaechea M, Giuseppucci C, de Badiola F, Bortagaray J, Perea C. Simplified surgical approach to congenital megaprepuce: fixing, unfurling and tailoring revisited. J Urol. 2011 Jun;185(6 Suppl):2487-90. doi: 10.1016/j.juro.2011.01.015. Epub 2011 Apr 27.
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