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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2024-10-29

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.

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Detailed Description

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Conditions

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Penile Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard Tubularized incised plate urethroplasty (sTIPU)

Group Type ACTIVE_COMPARATOR

Repair surgery

Intervention Type PROCEDURE

1. a circumscribing skin incision was made 2 mm below the hypospadias meatus,
2. penile degloving,
3. the para-urethral plate incision was made,
4. A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans.
5. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture.
6. The neomeatus was formed on a catheter 2 F larger than the urethral stent.
7. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty.
8. 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.

Preputial inlay graft urethroplasty (PIGU)

Group Type ACTIVE_COMPARATOR

Repair surgery

Intervention Type PROCEDURE

1. a circumscribing skin incision was made 2 mm below the hypospadias meatus,
2. penile degloving,
3. the para-urethral plate incision was made,
4. A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans.
5. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture.
6. The neomeatus was formed on a catheter 2 F larger than the urethral stent.
7. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty.
8. 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.

Interventions

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Repair surgery

1. a circumscribing skin incision was made 2 mm below the hypospadias meatus,
2. penile degloving,
3. the para-urethral plate incision was made,
4. A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans.
5. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture.
6. The neomeatus was formed on a catheter 2 F larger than the urethral stent.
7. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty.
8. 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Children age more than 12 months to 12 years.
2. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)

Exclusion Criteria

1. Circumcised
2. Ventral Penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate).
3. Uretheral plate less than 6mm
4. Megameatus intact prepuce
5. Albumin less than 3.5 g/dL

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No