NCT05666206

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

December 17, 2022

Last Update Submit

February 10, 2024

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

  • Success of surgery

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

    3 months

Secondary Outcomes (1)

  • complications of hypospadias surgery

    3 months

Study Arms (2)

Fibrin group

ACTIVE COMPARATOR

Fibrin sealant covered with 2ry dartos flap.

Procedure: fibrin sealant in hypospadias

Standard TIP technique

ACTIVE COMPARATOR

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

Procedure: fibrin sealant in hypospadias

Interventions

fibrin sealant in hypospadiasPROCEDURE

fibrin sealant will be used over the suture line

Fibrin groupStandard TIP technique

Eligibility Criteria

Age3 Months - 18 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - AlAzhar university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hypospadias

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Mohamed F Salman, MD

CONTACT

+201111788996Prof_mohamed_fawzy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 17, 2022

First Posted

December 27, 2022

Study Start

January 1, 2022

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

EG(1)