Distal Hypospadias Repair Outcome

Not Applicable

Not yet recruiting

• Conditions: Distal Penile Hypospadias (Disorder)

• Registration Number: NCT06700629
• Lead Sponsor: Armia Ezzat Thabet Azer

Brief Summary

Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair

Detailed Description

Hypospadias is a congenital deformity where the opening of the urethra (the meatus) is sited on the underside (ventral) part of the penis, anywhere from the glans to the perineum.

It occurs in 1 in 250 live male births. it is often associated with "hooded" foreskin and chordee (ventral curvature of the penis shaft).

Hypospadias can be classified according to the anatomical location of meatus:

Distal-anterior hypospadias (located on the glans or distal shaft of the penis and the most common type of hypospadias) Intermediate-middle (penile). Proximal-posterior (penoscrotal, scrotal, perineal).

Diagnosis includes a description of the local findings:

Position, shape and width of the orifice Presence of atretic urethra and division of corpus spongiosum Appearance of the preputial hood and scrotum Size of the penis Curvature of the penis on erection. Aim of hypospadias surgery :(2) Is to correct penile curvature,to form neo-urethera of an adequate size, to bring the neomeatus to the tip of glans, and offer satisfactory cosmetic results.

The ideal age at surgery for primary hypospadias repair is usually 6-18 months. The complication rate is about 10% in distal hypospadias repair.

Complications include:

1. uretherocutaneous fistula.

2. meatal stenosis.

3. urethral stricture.

4. Urethral diverticulum. After hypospadias repairs, long-term follow-up is necessary, up to adolescence, to detect urethral stricture, voiding dysfunction and recurrent penile curvature.

Study Timeline

• Study First Submitted: 2024-09-10
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2025-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Child with distal hypospadias, uncircumcised , without meatal stenosis and no previous surgery for hypospadias

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Exclusion Criteria

• Any surgical manipulation includes circumcision or meatotomy. Patient refusal to be enrolled in the research. Patient lost follow up in the first six months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional outcome of Distal Penile Hypospadias Repair	Six months postoperatively	Functional Outcome of Distal Hypospadias Repair. Outcome Measure Title: Post-void Residual Volume (PVR) Measured via Abdominal Ultrasound Description: Assessment of urinary function through post-void residual volume using ultrasound, reported in milliliters (mL).; Time Frame: six months postoperatively.

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcome of Distal Penile Hypospadias Repair	Six months postoperatively	Cosmetic Outcome of Distal Hypospadias Repair. Outcome Measure Title: Aesthetic Evaluation Based on Photographic Documentation Description: Assessment of cosmetic outcomes using photographs taken on postoperative days 0 (immediately after surgery), 3, and 5-7 (during catheter removal), scored on a 5-point Likert scale (1 = poor, 5 = excellent).; Time Frame: Six months postoperatively.
Complication Rate Following Distal Hypospadias Repair	Weekly assessments during the first month and monthly assessments for the following five months postoperatively.	Complication Rate Following Distal Hypospadias Repair. Outcome Measure Title: Frequency of Postoperative Complications; Description: Detection and quantification of specific complications, including: Edema of the glans or penile skin. Hematoma. Infection. Wound dehiscence. Urethrocutaneous fistula. Meatal stenosis. Urethral stricture. Urethral diverticula. Data will be reported as the number and percentage of patients experiencing each complication.; Time Frame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
Patient-Reported Outcomes	Six months postoperatively	Patient-Reported Outcomes. Outcome Measure Title: Satisfaction Score as Reported by Patients or Caregivers Description: Patients or their relatives will report satisfaction with surgical outcomes on a Visual Analog Scale (VAS) ranging from 0 (not satisfied) to 10 (very satisfied).; Time Frame: Six months postoperatively.

Trial Locations

Locations (2)

Noha Elabody; 🇪🇬 Assiut, Egypt

Faculty Of Medicine Assiut University; 🇪🇬 Assiut, Egypt