Preputial Graft Urethroplasty in Primary Repair of Hypospadias

Completed Clinical Trial

— Hypospadias  

Official title:

Aswan University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660564
• Other study ID #: AswanUH5
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2022
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction: Hypospadias repair is debated. There has been no perfect procedure until this moment. A graft is sometimes needed to fundamentally strengthen the narrow urethral plate.

Patients and methods: The study included a child who had primary distal or mid-penile hypospadias at the age of 6 months or more, a urethral plate less than 8 mm in a non-circumcised penis, and was operated on using the Snodgraft technique.

Description:

Patients and methods This study was designed as a prospective cross-sectional study during the period from May 2018 to October 2019. The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.

Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis. Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.

History has been taken from the parent of the patient in the form of the direction of the urine stream, manifestation of urinary tract infection, past history and previous repair, family history of hypospadias among first-degree relatives, history of hormonal intake (local or systemic), gestational history as a history of acute or chronic diseases, and exposure to drugs or environmental endocrinological disrupters.

Physical examination as body weight, other associated congenital anomalies, and other medical problems. Local examination of the external genitalia includes the penile size and length (normal or small penis). The meatus was examined for its position, caliber, and presence or absence of surrounding shiny skin. The prepuce was examined for shape and width (complete or incomplete). The shape and width of the glens were examined (cleft, incomplete cleft, flat). The urethral plate was examined for its width, length, or associated urethral dysplasia. If and to what extent there is or is not penile curvature, scrotal transposition, or penile rotation, Examination of the scrotal wall is either well developed or underdeveloped. Examination of the scrotal contents: palpation of the testis, whether it is present or absent (undescended), its site, size, bilateral symmetry, or any associated problem such as a congenital hernia or hydrocele.

Routine investigations such as CBCS, PT, PC, urine analysis, and urine culture if necessary. Abdominopelvic ultrasonography to rule out associated congenital anomalies. Before general anesthesia was administered, all patients received a preoperative dose of IV 3rd generation cephalosporins (50 mg/kg). Then the caudal block was done to reduce the post-operative pain. Patients are placed in a supine position, and sterilization and toweling are done to expose the external genitalia.

Preoperative measurements were taken after induction of anesthesia before the start of the operation; penile girth, urethral plate length, urethral plate width, vertical length of the glans (Fig. 2A), and maximum width of the glans .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2019
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 6 Months to 8 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis.

Exclusion Criteria:

• . Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.

Related Conditions & MeSH terms

• Completed

Intervention

Procedure:
• DIGU Dorsal inlay preputial graft urethroplasty
Using a scalpel, a midline incision is made from the meatus to the end of the plate . The edge of the distal glans should not be incised to avoid meatal stenosis. The depth of this relaxing incision depends on the plate's width and depth, but in all cases, it extends down to the corpora cavernosa. Degloving of the penile skin to the penoscrotal junction If a minimal chord is present, it should be corrected. From the inner prepuce, a free graft was measured, harvested, defatted, and stitched to the UP. With interrupted 6/0 polyglactin sutures running from the old meatus to the tip of the glans, the graft was secured to the medial edges of the incised plate. Depending on the location of the meatus, the characteristics of the UP, and the depth of the midline incision, the graft width and length varied in each case.

Locations

Country	Name	City	State
Egypt	Sarah Magdy Abdelmohsen	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Magdy Abdelmohsen	Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	75% success rate		one and half year