NCT05960123

Brief Summary

The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3.8 years

First QC Date

July 10, 2023

Last Update Submit

July 21, 2023

Conditions

HypospadiasComplication,Postoperative

Keywords

Distal and midpenile hypospadiasTIPUSpongioplasty-dartosoraphypediatric HOSE

Outcome Measures

Primary Outcomes (3)

  • Urethrocutaneous fistula

    Rate of fistula

    12 months

  • meatal stenosis

    Rate of metal stenosis

    12 months

  • glans dehiscence

    Rate of glans dehiscence

    12 months

Other Outcomes (1)

  • Cosmetic results

    12 months

Study Arms (2)

Group with Spongioplasty

ACTIVE COMPARATOR

patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement

Procedure: Tubularized Incised Plate (TIP) urethroplasty

Group without Spongioplasty

ACTIVE COMPARATOR

patients underwent TIPU with dorsal dartos flap interposition without spongioplasty

Procedure: Tubularized Incised Plate (TIP) urethroplasty

Interventions

Tubularized Incised Plate (TIP) urethroplastyPROCEDURE

tubularization of urethral plate with or without spongioplasty

Group with SpongioplastyGroup without Spongioplasty

Eligibility Criteria

Age6 Months - 14 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsthis anomalies of male genitalia
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

You may not qualify if:

  • recurrent cases Proximal; hypospadias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammad Daboos

Cairo, Select, 115678, Egypt

Location

MeSH Terms

Conditions

HypospadiasPostoperative Complications

Interventions

Lysine Acetyltransferase 5

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 AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histone AcetyltransferasesLysine AcetyltransferasesAcetyltransferasesAcyltransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatric surgery

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 25, 2023

Study Start

April 1, 2019

Primary Completion

January 1, 2023

Study Completion

May 30, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)