Back to resultsIsoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair
Primary Purpose
Hypospadias
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cyanoacrylate, Isobutyl
Classic surgical repair
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias focused on measuring Isoamyl 2-cyanoacrylate, urethrocutaneous fistula, fistula repair, hypospadias
Eligibility Criteria
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
Sites / Locations
- Urology department - ain shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cases of group (I) cyanoacrylate glue
Cases of the control group (II) , classic repair
Arm 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.
Outcomes
Primary Outcome Measures
successful repair of the fistula
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
Secondary Outcome Measures
postoperative complications
report of the possible postoperative complications of both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04876976
Brief Title
Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair
Official Title
Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
Keywords
Isoamyl 2-cyanoacrylate, urethrocutaneous fistula, fistula repair, hypospadias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
patients and their relatives were blinded to the type of the intervention
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cases of group (I) cyanoacrylate glue
Arm Type
Experimental
Arm Description
Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.
Arm Title
Cases of the control group (II) , classic repair
Arm Type
Active Comparator
Arm Description
Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
Intervention Type
Drug
Intervention Name(s)
Cyanoacrylate, Isobutyl
Intervention Description
using cyanoacrylate in the surgical repair of urethro-cutaneous fistula
Intervention Type
Procedure
Intervention Name(s)
Classic surgical repair
Intervention Description
classical repair of urethro-cutaneous fistula without the use of cyanoacryalte
Primary Outcome Measure Information:
Title
successful repair of the fistula
Description
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
postoperative complications
Description
report of the possible postoperative complications of both groups
Time Frame
6 months after surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Hypospadias is a male urethral congenital anomaly
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Urology department - ain shams university
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair
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