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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03911635
Other study ID # URAGPI in hypospadias
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date March 1, 2021

Study information

Verified date January 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date March 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 1 Year to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
URAGPI technique
the Urethral Advancement, Glanuloplasty and Preputioplasty

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks evaluation according to "Hypospadias Objective Penile Evaluation Score" 3 weeks
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