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Not yet recruitingNCT06700629Updated Nov 22, 2024

Distal Hypospadias Repair Outcome

An interventional study of Distal Penile Hypospadias (Disorder) in Distal Penile Hypospadias (Disorder), sponsored by Armia Ezzat Thabet Azer. Not yet recruiting at 2 sites in Egypt. Open to male participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Armia Ezzat Thabet Azer · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
1 Year and older
Sex
Male
01

Study summary

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

Read the 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.
02

Conditions studied

  • Distal Penile Hypospadias (Disorder)

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Keywords

  • Penile Hypospadias
03

In context

Hypospadias

131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 102 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

This is the only study on the registry with Armia Ezzat Thabet Azer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    DPH repair outcome

    Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): A. Preoperative preparation: All patients will be subjected to evaluation including: 1. Measurement of penile length and width (in cm). 2. The shape of glans. (clefted , incomplete ceft, flat) 3. Glans size is measured by cubic centimetres. 4. Presence or absence of chordee and its degree. 5. Urethral plate condition and it's length, width and surface area. 6. Condition of skin over the urethra. 7. Presence of penile torsion. All patients should undergo preoperative surgical fitness including; complete blood picture, prothrombin time, concentration and INR, ECG and renal function test. Prophylactic systemic antibiotics are given intraoperatively.

    Procedure: Distal Penile Hypospadias (Disorder)

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

    Also known as: Distal Penile Hypospadias repair outcome

06

What researchers measure

Primary outcomes

  1. Functional outcome of Distal Penile Hypospadias Repair

    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.

    Time frame: Six months postoperatively

Secondary outcomes

  1. Cosmetic outcome of Distal Penile Hypospadias Repair

    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.

    Time frame: Six months postoperatively

  2. Complication Rate Following Distal Hypospadias Repair

    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.

    Time frame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.

  3. Patient-Reported Outcomes

    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.

    Time frame: Six months postoperatively

07

Study locations

2 sites
  • Noha Elabody
    Assiut, 71111, Egypt
  • Faculty Of Medicine Assiut University
    Assiut, 71511, Egypt
08

References and documents

Publications

  • 1) Belman AB. Hypospadias and chordee. In: Belman AB, King LR, Kramer SA, eds. Clinical Pediatric Urology. 4th edn. London, Martin Dunitz, 2002, pp. 1061-1092. 2) Mouriquand OD, Mure PY. Hypospadias. In: Gearhart J, Rink R, Mouriquand PDE, eds. Pediatric Urology, Philadelphia, WB Saunders, 2001, pp. 713-728. 3) Snodgrass W (1994) Tubularized, incised plate urethroplasty for distal hypospadias 151: 464-465. 4) Duckett JW Jr, Kaplan GW, Woodard JR, Devine CJ Jr (1980) Panel: complications of hypospadias repair 7: 443-454. 5) Braga LHP, Lorenzo AJ, Pippi Salle JL. Tubularized incised plate urethroplasty for distal hypospadias: A literature review. Indian J Urol 2008 Apr; 24(2)219-25. 6) Allen TD,Spence HM: The Surgical Treatment Of Coronal hypospadias and related problems , J. Urol 100:504, 1968. 7) Holland AJA, Smith GHH, Ross Fl, et al. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int 2001;88:255-8. 8) Hinman F. Penis: Plastic operation. In: Atlas of urologic surgery 2nd ed. Philadelphia; WB Saunders, 1998:96-157. 9) Abdul-Ghafoor B, Al-Dabbagh H. Primary distal hypospadias repair: tubularized incised plate urethroplasty (Snodgrass) versus the perimeatal based flap (Mathieu). Iraqi J Com Med 2009; 23-1. Rabnowitz R. and Hulbert W.C: Meatal-based flap Mathieu procedure. Adult and Pediatric. Saunders, Philadelphia, pp 39-43, 1999
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06700629
Lead sponsor
Armia Ezzat Thabet Azer
Responsible party
Armia Ezzat Thabet Azer (Resident physician, Assiut University) — Sponsor-investigator
First posted
Nov 22, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Nov 22, 2024

Study contacts

Armia Ezzat Thabet Azer, bachelor degree
Contact
armia.ezzat@yahoo.com
+201096067142

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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