Efficacy of Fibrin Sealant in Hypospadias Surgery

Hypospadias Clinical Trial

Official title:

Efficacy of Fibrin Sealant in Hypospadias Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666206
• Other study ID #: Fibrin sealant in hypospadius
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: Mohamed F Salman, MD
• Phone: +201111788996
• Email: Prof_mohamed_fawzy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.

Description:

Many procedures have been tried for the sake of proper management of hypospadias and reducing the complications. Of them, tabularized incised plate (TIP) is one of the most convenient technique, which became the most common procedure for hypospadias repair (Elsayem et al., 2022). Although many surgical modifications and techniques have been prescribed to minimize post-operative complications and improve outcomes, a high percentage of complications still occurs. Urethrocutaneous fistulae are the most common post-operative complication (10%-40%) after hypospadias surgery; other complications being skin flap related complications such as flap necrosis, suture line breakdown, ascent of the testis and penile torsion (Shenoy et al.,2021). In this thesis a secondary preputial dartos flap will be performed in all cases and we will evaluate the value of usage of fibrin glue on the 1ry suture line .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria All treatment naïve children with hypospadias.

Exclusion Criteria:

• Adult hypospadias.
• Recurrent cases.
• Prio pelvic trauma or radiation.

Related Conditions & MeSH terms

• Hypospadias

Intervention

Procedure:
• fibrin sealant in hypospadias
fibrin sealant will be used over the suture line

Locations

Country	Name	City	State
Egypt	Urology department - AlAzhar university	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of surgery	Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.	3 months
Secondary	complications of hypospadias surgery	Number of patients with fistula, chordee, rotation, ....	3 months