NCT06413901

Brief Summary

Objective: To study the effect of tubularizing the urethral plate in DPH in children using 2 different absorbable suture materials, rapidly absorbable, braided 6/0 Vicryl and slowly absorbable monofilament 6/0 Polydioxanone, on complication rates. Patients and methods: A prospective, randomized controlled study conducted at the Urology Department, Cairo University Specialized Pediatric Hospital, Abou El Reesh, between September 2021 and September 2022. A total of 69 boys aged between 8 and 120 months with DPH were randomly divided into 2 groups: group(A) Vicryl included 39 boys and group(B) PDS included 30 boys. All boys were uncircumcised with no chordee and were primary repairs. TIP was the surgical technique used by a single pediatric urologist. Follow up was performed in outpatient clinic at 7 days, 1, 3, 6 and 12 months postoperatively. The complications and reoperation rates for both groups were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

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

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 5, 2024

Last Update Submit

May 10, 2024

Conditions

Hypospadias Repair

Outcome Measures

Primary Outcomes (1)

  • complication rate

    urethrocutaneous fistula, wound infection, wound dehiscence, overall complications, and reoperation rates

    one year

Study Arms (2)

Vicryl group

EXPERIMENTAL

TIP hypospadias repair

Procedure: TIP

PDS group

EXPERIMENTAL

TIP hypospadias repair

Procedure: TIP

Interventions

TIPPROCEDURE

TIP hypospadias repair

PDS groupVicryl group

Eligibility Criteria

Age6 Months - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Any child(aged from 6m to 12 years old) with distal penile hypospadias (DPH) ( uncircumcised, without chordae, with good penile size and urethral plate(candidates for T.I.P repair)

You may not qualify if:

  • reccurent cases,
  • circumcised cases
  • other types of hypospadias rather than DPH,
  • presence of chordae,
  • poor urethral plate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 5, 2024

First Posted

May 14, 2024

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

EG(1)