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

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

Study Overview

• Status: Recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: Snodgrass repair; Procedure: Snodgrass repair with graft

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed S Gebaly Adam, Resident; Phone Number: +2001126314479; Email: ahmedshawky@med.sohag.edu.eg
• Study Contact Backup: Name: Tarek A Siefin, Lecturer; Phone Number: +200109 880 4947

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University hospitals
    • Contact: Ahmed S Gebaly Adam; Phone Number: +2001002372157; Email: ahmedshawky@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Snodgrass repair group; A relaxing incision is made in the midline by using scalpel or scissors from Within the meatus to the end of the plate. A 6 F stent is passed into the bladder. The neourethra is closed using a fine suture, 7-0 or 6-0 vicryl sutures in two-layer.	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
Active Comparator: Snodgrass repair with graft group; A relaxing incision is made in the midline by using scalpel or scissors A free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate after the urethral plate was incised he graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Stock JA, Scherz HC, Kaplan GW. Distal hypospadias. Urol Clin North Am. 1995 Feb;22(1):131-8.
• 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/s11255-016-1416-7. Epub 2016 Sep 13.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: Soh-Med-23-12-06MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No