Preputial Graft Urethroplasty in Primary Repair of Hypospadias (Hypospadias)

Aswan University Hospital

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.

Study Overview

• Status: Completed
• Conditions: Completed
• Intervention / Treatment: Procedure: DIGU Dorsal inlay preputial graft urethroplasty

Detailed 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 .

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11331
    • Sarah Magdy Abdelmohsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 6 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
75% success rate	one and half year

Collaborators and Investigators

• Sponsor: Sarah Magdy Abdelmohsen
• Collaborators: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Estimate): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AswanUH5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No