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

NCT06405763 | Recruiting

• 1 other identifier: Soh-Med-23-12-06MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Snodgrass repair group

ACTIVE COMPARATOR

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

Snodgrass repair with graft group

ACTIVE COMPARATOR

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

Interventions

Snodgrass repair PROCEDURE

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 group

Snodgrass repair with graft PROCEDURE

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

Snodgrass repair with graft group

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Proximal and mid penile hypospadias with marked chordae
• previous hypospadias repair

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, 82511, Egypt

RECRUITING

Related Publications (4)

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

  PMID: 7855949 RESULT

• 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.

  PMID: 27623810 RESULT

• 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.

  PMID: 37470555 RESULT

• 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.

  PMID: 11488741 RESULT

MeSH Terms

Conditions

Hypospadias

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Ahmed S Gebaly Adam, Resident

CONTACT

+2001126314479; ahmedshawky@med.sohag.edu.eg

Tarek A Siefin, Lecturer

CONTACT

+200109 880 4947

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at urology department, Sohag university hospitals

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 8, 2024
• Study Start: December 11, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

EG (1)