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

Assiut University

Status: Not yet enrolling

Conditions: Penile Hypospadias

Treatments: Procedure: Repair surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05528276

hypospadias repair

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Male

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

standard Tubularized incised plate urethroplasty (sTIPU)

Active Comparator group

Treatment:

Procedure: Repair surgery

Preputial inlay graft urethroplasty (PIGU)

Active Comparator group

Treatment:

Procedure: Repair surgery