An observational study in Congenital Urogenital Anomaly, sponsored by Hospital Universitario San Ignacio. Withdrawn at 1 site in Colombia. Open to male participants aged 1 Month to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Hospital Universitario San Ignacio · Observational
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.
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.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
Browse Congenital Abnormalities studies →Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
Compared within Congenital Abnormalities, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.
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Exclusion Criteria:
Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers
Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers
Hypospadias Hematoxylin-eosin and smooth muscle actin markers
Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers
Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers
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.
Differences in the distribution of the smooth Muscle In Dartos
Smooth Muscle Fibers
Time frame: 1 year
Describe the pattern of smooth muscle in patients with megaprepuce
Smooth Muscle Fibers
Time frame: 1 year
Describe the pattern of smooth muscle in patients with hypospadias
Smooth Muscle Fibers
Time frame: 1 year
Plan to share: No
Ran from Sep 2017 to primary completion in Mar 2024, 77 months.
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This study is withdrawn, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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