Efficacy of Fibrin Sealant in Hypospadias Surgery

• Sponsor: Al-Azhar University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05666206
• Collaborator: Benha University (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 11.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypospadias	Procedure: fibrin sealant in hypospadias	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Fibrin Sealant in Hypospadias Surgery
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Success of surgery [3 months]

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

Secondary Outcome Measures

1. complications of hypospadias surgery [3 months]

   Number of patients with fistula, chordee, rotation, ....

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 18 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Inclusion criteria All treatment naïve children with hypospadias.

Exclusion Criteria:

• Adult hypospadias.

• Recurrent cases.

• Prio pelvic trauma or radiation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology department - AlAzhar university	Cairo		Egypt

Sponsors and Collaborators

• Al-Azhar University
• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05666206
• Other Study ID Numbers: Fibrin sealant in hypospadius
• First Posted: Dec 27, 2022
• Last Update Posted: Dec 27, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypospadias; Fibrin Tissue Adhesive

Study Results

No Results Posted as of Dec 27, 2022