Efficacy of Fibrin Sealant in Hypospadias Surgery

NCT ID: NCT05666206

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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 .

Conditions

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibrin group

Fibrin sealant covered with 2ry dartos flap.

Group Type ACTIVE_COMPARATOR

fibrin sealant in hypospadias

Intervention Type PROCEDURE

fibrin sealant will be used over the suture line

Standard TIP technique

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

Group Type ACTIVE_COMPARATOR

fibrin sealant in hypospadias

Intervention Type PROCEDURE

fibrin sealant will be used over the suture line

Interventions

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fibrin sealant in hypospadias

fibrin sealant will be used over the suture line

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* Adult hypospadias.
* Recurrent cases.
* Prio pelvic trauma or radiation.
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fawzy Abd Elfattah Salman

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urology department - AlAzhar university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed F Salman, MD

Role: CONTACT

+201111788996

Facility Contacts

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Mohamed F Salman, MD

Role: primary

+201111788996

Other Identifiers

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Fibrin sealant in hypospadius

Identifier Type: -

Identifier Source: org_study_id

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