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Trial record 24 of 117 for:    "Penile Disease"

Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03911635
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
Ali Ahmed, Assiut University

Brief Summary:

Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis.

Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty " URAGPI" versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion.

B) Normal appearance of the penis. C) Good functional results.

Condition or disease Intervention/treatment Phase
Hypospadias Procedure: URAGPI technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: Hypospadias in children
Distal shaft hypospadias at age of 12 years or less
Procedure: URAGPI technique
the Urethral Advancement, Glanuloplasty and Preputioplasty

Primary Outcome Measures :
  1. Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks [ Time Frame: 3 weeks ]
    evaluation according to "Hypospadias Objective Penile Evaluation Score"

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al

Exclusion Criteria:

  • circumcised patients
  • sever degrees of chordae
  • previous surgical repair
  • meatal stenosis

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Responsible Party: Ali Ahmed, Principal Investigator, Assiut University Identifier: NCT03911635     History of Changes
Other Study ID Numbers: URAGPI in hypospadias
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities