Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias

Hypospadias Clinical Trial

Official title:

Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405763
• Other study ID #: Soh-Med-23-12-06MS
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 10, 2024

Study information

• Verified date: May 2024
• Source: Sohag University
• Contact: Ahmed S Gebaly Adam, Resident
• Phone: +2001126314479
• Email: ahmedshawky[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm

Description:

The main goal for hypospadias repair is to achieve both cosmetic and functional normality.

Several surgical techniques for hypospadias repair have been developed that depend on the site of the urethral meatus in children The effect of the urethral plate characteristics on the surgical outcome of Snodgrass repair has been studied in many series. Some documented that urethral plate width has a significant impact on the complication rates Holland and Smith reported a high complication rate in Snodgrass repair with a urethral plate width of less than 8 mm 7 The augmentation of the urethral plate either with inlay graft (DIGU, Snodgraft, or G-TIP), Onlay preputial flap, or other flaps carries a better outcome than the original TIP in many studies Others denied any effect of the narrow urethral plate on the success rate We aim in this study to determine which is better in narrow urethral plate in distal penile hypospadias, as regarding surgical and cosmetic outcomes; Snodgrass or combined inner preputial graft with Snodgrass

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Months to 16 Years

Eligibility

Inclusion Criteria:

Children age: > 6m up to 16y

• Distal penile hypospadias(distal shaft,coronal,subcoronal )

• mid penile hypospadias with mild chordae les 30 degree

• Urethral plate <8 mm in maximum transverse diameter before the midline urethral plate incision .Primary non-circumcised cases of hypospadias

Exclusion Criteria:

• Proximal and mid penile hypospadias with marked chordae

• previous hypospadias repair

Related Conditions & MeSH terms

• Hypospadias

Intervention

Procedure:
• Snodgrass repair
A relaxing incision is made in the midline by using scalpel or scissors A 6 F stent is passed into the bladder. The neourethra is closed
• Snodgrass repair with graft
A relaxing incision is made in the midline by using scalpel or scissors In grafted Snodgrass repairA free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate The graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed

Locations

Country	Name	City	State
Egypt	Sohag University Hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Elmoghazy H, Hussein MM, Mohamed E, Badawy A, Alsagheer G, Abd Elhamed AM. A novel technique for repair of mid-penile hypospadias using a preputial skin flap: results of 110 patients. Int Urol Nephrol. 2016 Dec;48(12):1943-1949. doi: 10.1007/s11255-016-14 — View Citation

Holland AJ, Smith GH, Ross FI, Cass DT. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int. 2001 Aug;88(3):255-8. doi: 10.1046/j.1464-410x.2001.02280.x. — View Citation

Nerli RB, Chandra S, Rai S, Dixit NS. Grafted tubularised incised plate: A right option in the management of failed mid-penile and distal hypospadias. Afr J Paediatr Surg. 2023 Jul-Sep;20(3):197-201. doi: 10.4103/ajps.ajps_19_22. — View Citation

Stock JA, Scherz HC, Kaplan GW. Distal hypospadias. Urol Clin North Am. 1995 Feb;22(1):131-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in functional outcome by evaluation of the stream an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining.	12 months
Primary	Cosmetic outcome	Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in cosmetic outcome By Hypospadias Objective penile Evaluation (HOPE) Score 1.meatus position 2.meatus shape 3.glans shape 4.penile skin shape 5.penile axis secreal 6.Torsion	12 months