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Efficacy of Fibrin Sealant in Hypospadias Surgery

Primary Purpose

Hypospadias

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fibrin sealant in hypospadias
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias

Eligibility Criteria

3 Months - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria All treatment naïve children with hypospadias. Exclusion Criteria: Adult hypospadias. Recurrent cases. Prio pelvic trauma or radiation.

Sites / Locations

  • Urology department - AlAzhar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fibrin group

Standard TIP technique

Arm Description

Fibrin sealant covered with 2ry dartos flap.

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

Outcomes

Primary Outcome Measures

Success of surgery
Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.

Secondary Outcome Measures

complications of hypospadias surgery
Number of patients with fistula, chordee, rotation, ....

Full Information

First Posted
December 17, 2022
Last Updated
February 14, 2023
Sponsor
Al-Azhar University
Collaborators
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05666206
Brief Title
Efficacy of Fibrin Sealant in Hypospadias Surgery
Official Title
Efficacy of Fibrin Sealant in Hypospadias Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
Collaborators
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrin group
Arm Type
Active Comparator
Arm Description
Fibrin sealant covered with 2ry dartos flap.
Arm Title
Standard TIP technique
Arm Type
Active Comparator
Arm Description
standard TIP technique with second dartos flap and no use of fibrin sealant
Intervention Type
Procedure
Intervention Name(s)
fibrin sealant in hypospadias
Intervention Description
fibrin sealant will be used over the suture line
Primary Outcome Measure Information:
Title
Success of surgery
Description
Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
complications of hypospadias surgery
Description
Number of patients with fistula, chordee, rotation, ....
Time Frame
3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria All treatment naïve children with hypospadias. Exclusion Criteria: Adult hypospadias. Recurrent cases. Prio pelvic trauma or radiation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
Prof_mohamed_fawzy@yahoo.com
Facility Information:
Facility Name
Urology department - AlAzhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
Prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Fibrin Sealant in Hypospadias Surgery

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