Efficacy of Fibrin Sealant in Hypospadias Surgery

February 10, 2024 updated by: Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Urology department - AlAzhar university
        • Contact:
        • Principal Investigator:
          • Mohamed F Salman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion criteria All treatment naïve children with hypospadias.

Exclusion Criteria:

  • Adult hypospadias.
  • Recurrent cases.
  • Prio pelvic trauma or radiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fibrin group
Fibrin sealant covered with 2ry dartos flap.
Procedure: fibrin sealant in hypospadias
fibrin sealant will be used over the suture line
Active Comparator: Standard TIP technique
standard TIP technique with second dartos flap and no use of fibrin sealant
Procedure: fibrin sealant in hypospadias
fibrin sealant will be used over the suture line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of surgery
Time Frame: 3 months
Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications of hypospadias surgery
Time Frame: 3 months
Number of patients with fistula, chordee, rotation, ....
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 17, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fibrin sealant in hypospadius

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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