NCT03295175

Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis

Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hospital Universitario San Ignacio · Academic / Other
• Sex: Male
• Age: 1 Month – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Urogenital Anomaly

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hematoxylin-eosin and smooth muscle actin markers	The foreskin arrives oriented in a single piece in formol to the unit of pathology, and in the pathology unit, they must: 1. Measure the length, width and thickness of the specimen. The specimen should include skin and mucosa with the underlying areolar tissue. 2. Examine the surfaces of the sample searching lesions, and describe them in size, appearance (warty, papillary, ulcerated), depth of invasion, and distance from the nearest cutting edge, if they are present.

Timeline

• Start date: 2017-09-21
• Primary completion: 2024-03-12
• Completion: 2024-03-12
• First posted: 2017-09-27
• Last updated: 2024-03-13

Locations

1 site across 1 country: Colombia