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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Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03295175
Acronym
DISMUD
Enrollment
0
Registered
2017-09-27
Start date
2017-09-21
Completion date
2024-03-12
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Urogenital Anomaly

Keywords

Congenital Abnormalities, Hypospadias, Congenital megaprepuce, Histology

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.

Interventions

DIAGNOSTIC_TESTHematoxylin-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.

Sponsors

Hospital Universitario San Ignacio
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
1 Months to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in the distribution of the smooth Muscle In Dartos1 yearSmooth Muscle Fibers
Describe the pattern of smooth muscle in patients with megaprepuce1 yearSmooth Muscle Fibers

Secondary

MeasureTime frameDescription
Describe the pattern of smooth muscle in patients with hypospadias1 yearSmooth Muscle Fibers

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026