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NCT Number: NCT06700629

Distal Hypospadias Repair Outcome

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

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Key information

Conditions

Distal Penile Hypospadias (Disorder) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

1 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Medicine Assiut University, Asyut, Asyut Governorate, Egypt

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distal Penile Hypospadias (Disorder)

Procedure

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:

  • Doctor (A) for Matheiu. ( 35 operations)
  • Doctor (M) for MAGPI. ( 35 operations)
  • 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

Other names: Distal Penile Hypospadias repair outcome

Primary outcomes

  1. Functional outcome of Distal Penile Hypospadias Repair

    Time frame: 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 outcomes

  1. Cosmetic outcome of Distal Penile Hypospadias Repair

    Time frame: 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.

  2. Complication Rate Following Distal Hypospadias Repair

    Time frame: 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.

  3. Patient-Reported Outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Armia Ezzat Thabet Azer, bachelor degree

CONTACT

[email protected]

+201096067142

Sponsors and collaborators

Lead sponsor

Armia Ezzat Thabet Azer

Other

Registry information

Official study title

Preoperative Predictors of Distal Hypospadias Repair Outcome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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