Efficacy of Fibrin Sealant in Hypospadias Surgery

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05666206

Enrollment

200

Registered

2022-12-27

Start date

2022-01-01

Completion date

2024-12-01

Last updated

2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Brief 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.

Detailed 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 .

Interventions

PROCEDUREfibrin sealant in hypospadias

fibrin sealant will be used over the suture line

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

3 Months to 18 Years

Healthy volunteers

Inclusion criteria

* Inclusion criteria All treatment naïve children with hypospadias.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Success of surgery	3 months	Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.

Secondary

Measure	Time frame	Description
complications of hypospadias surgery	3 months	Number of patients with fistula, chordee, rotation, ....

Countries

Egypt

Contacts

Primary ContactMohamed F Salman, MD

Prof_mohamed_fawzy@yahoo.com+201111788996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026