Skip to content

Distal Hypospadias Repair Outcome

Preoperative Predictors of Distal Hypospadias Repair Outcome

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06700629
Enrollment
50
Registered
2024-11-22
Start date
2025-01-01
Completion date
2026-06-30
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Penile Hypospadias (Disorder)

Keywords

Penile Hypospadias

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.

Interventions

PROCEDUREDistal Penile Hypospadias (Disorder)

Three operations which are Tubularized incised plate urethroplasty (TIP), Mathieu and meatal advancement and glanuplasty (MAGPI). A three experienced operators with number of operations done by each one more than one hundred operation in the last year. The operators will be fixed for each surgical technique as follows: 1. Doctor (A) for Matheiu. ( 35 operations) 2. Doctor (M) for MAGPI. ( 35 operations) 3. Doctor (S) for TIP ( 35 operations). Tubularized incised plate urethroplasty:(3,6) Indication: for distal penile hypospadias with or without penile curvature with any width of the uretheral plate and also for any type of distal hypospadias associated with curvature. Key steps for this operation are as follows: Glans retraction using stay suture 4-0 or 5-0 silk. Uretheral catheter pass through hypospadic meatus to bladder. Parallel longitudenal incision is done 1-2mm proximal to hypospadic meatus. A circumferential incision is made 2-3 mm below coronal sulcus dorsally

Sponsors

Armia Ezzat Thabet Azer
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Functional outcome of Distal Penile Hypospadias RepairSix months postoperativelyFunctional 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

MeasureTime frameDescription
Cosmetic outcome of Distal Penile Hypospadias RepairSix months postoperativelyCosmetic 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 RepairWeekly 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 OutcomesSix months postoperativelyPatient-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.

Countries

Egypt

Contacts

Primary ContactArmia Ezzat Thabet Azer, bachelor degree
armia.ezzat@yahoo.com+201096067142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026