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Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis (DISMUD)

H

Hospital Universitario San Ignacio

Status

Withdrawn

Conditions

Congenital Urogenital Anomaly

Treatments

Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

Study type

Observational

Funder types

Other

Identifiers

NCT03295175
FM-CIE-0319-17

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

1 month to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

Congenital Megaprepuce
Description:
Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers
Treatment:
Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers
Hypospadias
Description:
Hypospadias Hematoxylin-eosin and smooth muscle actin markers
Treatment:
Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers
Control
Description:
Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers
Treatment:
Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

Trial contacts and locations

1

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Central trial contact

Luis G Villarraga, MD; Jose N Fernandez, MD

Data sourced from clinicaltrials.gov

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