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

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ClinicalTrials.gov Identifier: NCT03295175
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario San Ignacio

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.


Condition or disease Intervention/treatment
Congenital Urogenital Anomaly Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : February 28, 2020

Group/Cohort Intervention/treatment
Congenital Megaprepuce
Congenital Megaprepuce 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.

Hypospadias
Hypospadias 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.

Control
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.




Primary Outcome Measures :
  1. Differences in the distribution of the smooth Muscle In Dartos [ Time Frame: 1 year ]
    Smooth Muscle Fibers

  2. Describe the pattern of smooth muscle in patients with megaprepuce [ Time Frame: 1 year ]
    Smooth Muscle Fibers


Secondary Outcome Measures :
  1. Describe the pattern of smooth muscle in patients with hypospadias [ Time Frame: 1 year ]
    Smooth Muscle Fibers



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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295175


Contacts
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Contact: Luis G Villarraga, MD 573114741627 luisga.villa@gmail.com
Contact: Jose N Fernandez, MD 57 314 3352500 nicolasfernandezb@gmail.com

Locations
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Colombia
Luis Gabriel Villarraga Recruiting
Bogotá, Colombia, 110231
Contact: Nicolas Fernandez, MD    5946161    nicolasfernandezb@gmail.com   
Principal Investigator: Jaime Perez, MD         
Principal Investigator: Nicolas Fernandez, MD         
Principal Investigator: Luis G Villarraga, MD         
Sub-Investigator: Eugenio Meek, MD         
Sub-Investigator: Maddy Mejia, MD         
Sponsors and Collaborators
Hospital Universitario San Ignacio
Investigators
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Principal Investigator: Jose N Fernandez, MD H

Additional Information:

Publications of Results:

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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT03295175     History of Changes
Other Study ID Numbers: FM-CIE-0319-17
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario San Ignacio:
Congenital Abnormalities
Hypospadias
Congenital megaprepuce
Histology
Additional relevant MeSH terms:
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Urogenital Abnormalities
Congenital Abnormalities