Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

Study Overview
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Brief Summary
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Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate & good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.

Official Title
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Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.

Conditions
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Penile Hypospadias

Intervention / Treatment
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* Procedure: Repair surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age more than 12 months to 12 years. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated) Exclusion Criteria: Circumcised Ventral Penile curvature ≥30° after penile degloving & artificial erection, (requiring transection of urethral plate). Uretheral plate less than 6mm Megameatus intact prepuce Albumin less than 3.5 g/dL

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard Tubularized incised plate urethroplasty (sTIPU)<br> | Procedure: Repair surgery<br>* a circumscribing skin incision was made 2 mm below the hypospadias meatus, penile degloving, the para-urethral plate incision was made, A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture. The neomeatus was formed on a catheter 2 F larger than the urethral stent. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty. A suitable urethral stent was left in situ for 7-10 days, with a compressive dressing applied. Grafted tubularised incised-plate . 1.Same steps but adding a graft (dorsal inlay) , 2. The graft will be taken from the inner preputial skin . 3. The graft will be sutured to overlying plate incision line from the old meatus to the tip of the glans.<br>|
| Active Comparator: Preputial inlay graft urethroplasty (PIGU)<br> | Procedure: Repair surgery<br>* a circumscribing skin incision was made 2 mm below the hypospadias meatus, penile degloving, the para-urethral plate incision was made, A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture. The neomeatus was formed on a catheter 2 F larger than the urethral stent. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty. A suitable urethral stent was left in situ for 7-10 days, with a compressive dressing applied. Grafted tubularised incised-plate . 1.Same steps but adding a graft (dorsal inlay) , 2. The graft will be taken from the inner preputial skin . 3. The graft will be sutured to overlying plate incision line from the old meatus to the tip of the glans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time. | the duration of the operation will be measured from the start of anesthesia to end. | intraoperative | 
| blood loss. | the amount of blood loss will be measured by CBC | one hour postoperatively | 
| site of the meatus | the meatal position will be measured in centimeters from the original position . | 6 months from the operation |