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NCT04876976 Clinical Trial

Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

Hypospadias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04876976
Other study ID # MS 75/2018
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2017
Est. completion date January 1, 2020

Study information
Verified date May 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cyanoacrylate, Isobutyl
using cyanoacrylate in the surgical repair of urethro-cutaneous fistula
Procedure:
• Classic surgical repair
classical repair of urethro-cutaneous fistula without the use of cyanoacryalte

Locations
Country Name City State
Egypt Urology department - ain shams university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 postoperative complications report of the possible postoperative complications of both groups 6 months after surgery
See also
  Status Clinical Trial Phase
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Completed NCT04239066 - Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Completed NCT03677453 - Interactive Perioperative Teaching Platform (IPTP) N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A