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
Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair
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:
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 →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.
Exclusion Criteria:
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)
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
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
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
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.
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
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