Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Operation time.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Operation time.
Time Frame: intraoperative
the duration of the operation will be measured from the start of anesthesia to end.
site of the meatus
Time Frame: 6 months from the operation
the meatal position will be measured in centimeters from the original position .
blood loss.
Time Frame: one hour postoperatively
the amount of blood loss will be measured by CBC
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdelrahman Mohamed Abdelkader
teaching assistant of urology & andrology
Assiut University
