Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

Phase 2

Completed

• Conditions: Hypospadias
• Interventions: Drug: Cyanoacrylate, Isobutyl; Procedure: Classic surgical repair

• Registration Number: NCT04876976
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2021-04-29
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Patients with Urethro-cutaneous fistula regardless of their age were included in our study.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cases of group (I) cyanoacrylate glue	Cyanoacrylate, Isobutyl	Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.
Cases of the control group (II) , classic repair	Classic surgical repair	Cases of the control group (II) underwent the same procedure without using cyanoacrylate.

Primary Outcome Measures

Name	Time	Method
successful repair of the fistula	6 months after surgery	surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present

Secondary Outcome Measures

Name	Time	Method
postoperative complications	6 months after surgery	report of the possible postoperative complications of both groups

Trial Locations

Locations (1)

Urology department - ain shams university; 🇪🇬 Cairo, Egypt