Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis
NCT ID: NCT03295175
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2017-09-21
2024-03-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Congenital Megaprepuce
Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Male patients scheduled for correction of hypospadias
* Male patients scheduled for circumcision for non-medical reasons.
Exclusion Criteria
1 Month
10 Years
MALE
Yes
Sponsors
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Hospital Universitario San Ignacio
OTHER
Responsible Party
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Principal Investigators
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Jose N Fernandez, MD
Role: PRINCIPAL_INVESTIGATOR
H
Locations
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Luis Gabriel Villarraga
Bogotá, , Colombia
Countries
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References
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Ruiz E, Vagni R, Apostolo C, Moldes J, Rodriguez H, Ormaechea M, Giuseppucci C, de Badiola F, Bortagaray J, Perea C. Simplified surgical approach to congenital megaprepuce: fixing, unfurling and tailoring revisited. J Urol. 2011 Jun;185(6 Suppl):2487-90. doi: 10.1016/j.juro.2011.01.015. Epub 2011 Apr 27.
Summerton DJ, McNally J, Denny AJ, Malone PS. Congenital megaprepuce: an emerging condition--how to recognize and treat it. BJU Int. 2000 Sep;86(4):519-22. doi: 10.1046/j.1464-410x.2000.00509.x.
Rod J, Desmonts A, Petit T, Ravasse P. Congenital megaprepuce: a 12-year experience (52 cases) of this specific form of buried penis. J Pediatr Urol. 2013 Dec;9(6 Pt A):784-8. doi: 10.1016/j.jpurol.2012.10.010. Epub 2012 Oct 30.
Alexander A, Lorenzo AJ, Salle JL, Rode H. The Ventral V-plasty: a simple procedure for the reconstruction of a congenital megaprepuce. J Pediatr Surg. 2010 Aug;45(8):1741-7. doi: 10.1016/j.jpedsurg.2010.03.033.
Borsellino A, Spagnoli A, Vallasciani S, Martini L, Ferro F. Surgical approach to concealed penis: technical refinements and outcome. Urology. 2007 Jun;69(6):1195-8. doi: 10.1016/j.urology.2007.01.065.
Spinoit AF, Van Praet C, Groen LA, Van Laecke E, Praet M, Hoebeke P. Congenital penile pathology is associated with abnormal development of the dartos muscle: a prospective study of primary penile surgery at a tertiary referral center. J Urol. 2015 May;193(5):1620-4. doi: 10.1016/j.juro.2014.10.090. Epub 2014 Oct 23.
Cimador M, Catalano P, Ortolano R, Giuffre M. The inconspicuous penis in children. Nat Rev Urol. 2015 Apr;12(4):205-15. doi: 10.1038/nrurol.2015.49. Epub 2015 Apr 7.
Maizels M, Zaontz M, Donovan J, Bushnick PN, Firlit CF. Surgical correction of the buried penis: description of a classification system and a technique to correct the disorder. J Urol. 1986 Jul;136(1 Pt 2):268-71. doi: 10.1016/s0022-5347(17)44837-3.
Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.
Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.
Hadidi AT. Buried penis: classification surgical approach. J Pediatr Surg. 2014 Feb;49(2):374-9. doi: 10.1016/j.jpedsurg.2013.09.066. Epub 2013 Nov 7.
Baskin LS, Himes K, Colborn T. Hypospadias and endocrine disruption: is there a connection? Environ Health Perspect. 2001 Nov;109(11):1175-83. doi: 10.1289/ehp.011091175.
Baskin LS, Ebbers MB. Hypospadias: anatomy, etiology, and technique. J Pediatr Surg. 2006 Mar;41(3):463-72. doi: 10.1016/j.jpedsurg.2005.11.059.
Fernandez N, Lorenzo A, Bagli D, Zarante I. Altitude as a risk factor for the development of hypospadias. Geographical cluster distribution analysis in South America. J Pediatr Urol. 2016 Oct;12(5):307.e1-307.e5. doi: 10.1016/j.jpurol.2016.03.015. Epub 2016 Apr 22.
Other Identifiers
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FM-CIE-0319-17
Identifier Type: -
Identifier Source: org_study_id
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