Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis

NCT03295175 | Withdrawn

• 1 other identifier: FM-CIE-0319-17
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Urogenital Anomaly

Keywords

Congenital Abnormalities; Hypospadias; Congenital megaprepuce; Histology

Outcome Measures

Primary Outcomes (2)

• Differences in the distribution of the smooth Muscle In Dartos

  Smooth Muscle Fibers

  1 year

• Describe the pattern of smooth muscle in patients with megaprepuce

  Smooth Muscle Fibers

  1 year

Secondary Outcomes (1)

• Describe the pattern of smooth muscle in patients with hypospadias

  1 year

Study Arms (3)

Congenital Megaprepuce

Congenital Megaprepuce Hematoxylin-eosin and smooth muscle actin markers

Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

Hypospadias

Hypospadias Hematoxylin-eosin and smooth muscle actin markers

Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

Control

Circumcision for non-medical reasons. Hematoxylin-eosin and smooth muscle actin markers

Diagnostic Test: Hematoxylin-eosin and smooth muscle actin markers

Interventions

Hematoxylin-eosin and smooth muscle actin markers DIAGNOSTIC_TEST

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.

Congenital Megaprepuce; Control; Hypospadias

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Male patients diagnosed with congenital megaprepuce and hypospadias scheduled for surgical correction.

You may qualify if:

• Male patients scheduled for correction of congenital megaprepuce
• Male patients scheduled for correction of hypospadias
• Male patients scheduled for circumcision for non-medical reasons.

You may not qualify if:

• Patients with a history of hypospadias correction.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Luis Gabriel Villarraga

Bogotá, 110231, Colombia

Location

Related Publications (14)

• 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.

  PMID: 21527191 RESULT

• 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.

  PMID: 10971284 RESULT

• 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.

  PMID: 23116700 RESULT

• 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.

  PMID: 20713233 RESULT

• 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.

  PMID: 17572214 RESULT

• 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.

  PMID: 25444989 RESULT

• 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.

  PMID: 25850928 RESULT

• 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.

  PMID: 2873259 RESULT

• Crawford BS. Buried penis. Br J Plast Surg. 1977 Jan;30(1):96-9. doi: 10.1016/s0007-1226(77)90046-7.

  PMID: 836989 RESULT

• Shenoy MU, Rance CH. Surgical correction of congenital megaprepuce. Pediatr Surg Int. 1999;15(8):593-4. doi: 10.1007/s003830050683.

  PMID: 10631746 RESULT

• 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.

  PMID: 24528990 RESULT

• 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.

  PMID: 11713004 RESULT

• 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.

  PMID: 16516617 RESULT

• 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.

  PMID: 27267992 RESULT

MeSH Terms

Conditions

Urogenital Abnormalities; Congenital Abnormalities; Hypospadias

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Penile Diseases; Genital Diseases, Male; Genital Diseases

Study Officials

• Jose N Fernandez, MD

  H

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: September 27, 2017
• Study Start: September 21, 2017
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)