Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

Study Overview
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Brief Summary
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cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair

Detailed Description
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Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair. cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique

Official Title
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Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.

Conditions
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Hypospadias

Intervention / Treatment
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* Drug: Cyanoacrylate, Isobutyl
* Procedure: Classic surgical repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Urethro-cutaneous fistula regardless of their age were included in our study. Exclusion Criteria: Patients with fistula size more than 5 mm multiple fistulas uncorrected obstruction distal to the fistula necrotic tissue active infection at the fistula site severely scarred skin deficient dartos around the fistula fistulas more proximal to the mid penile position recurrent fistulas previous history of hypersensitivity to cyanoacrylate-based products
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases of group (I) cyanoacrylate glue<br>Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. | Drug: Cyanoacrylate, Isobutyl<br>* using cyanoacrylate in the surgical repair of urethro-cutaneous fistula<br>|
| Active Comparator: Cases of the control group (II) , classic repair<br>Cases of the control group (II) underwent the same procedure without using cyanoacrylate. | Procedure: Classic surgical repair<br>* classical repair of urethro-cutaneous fistula without the use of cyanoacryalte<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful repair of the fistula | surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | report of the possible postoperative complications of both groups | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isoamyl 2-cyanoacrylate, urethrocutaneous fistula, hypospadias, fistula repair