Efficacy of Fibrin Sealant in Hypospadias Surgery

Al-Azhar University

Status: Enrolling

Conditions: Hypospadias

Treatments: Procedure: fibrin sealant in hypospadias

Study type: Interventional

Funder types: Other

Identifiers

NCT05666206

Fibrin sealant in hypospadius

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 200 estimated patients

Sex: Male

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria All treatment naïve children with hypospadias.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Fibrin group

Active Comparator group

Description:

Fibrin sealant covered with 2ry dartos flap.

Treatment:

Procedure: fibrin sealant in hypospadias

Standard TIP technique

Active Comparator group

Description:

standard TIP technique with second dartos flap and no use of fibrin sealant

Treatment:

Procedure: fibrin sealant in hypospadias