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

Not Applicable

Not yet recruiting

• Conditions: Penile Hypospadias
• Interventions: Procedure: Repair surgery

• Registration Number: NCT05528276
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-28
• Study Start: 2022-08-29
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preputial inlay graft urethroplasty (PIGU)	Repair surgery	-
standard Tubularized incised plate urethroplasty (sTIPU)	Repair surgery	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt