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CompletedNCT06413901Updated May 14, 2024

TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures

An interventional study of TIP in Hypospadias Repair, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Sep 2021, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
6 Months to 12 Years
Sex
Male
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Study 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.

02

Conditions studied

  • Hypospadias Repair

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03

In context

Hypospadias

131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's enrollment of 69 is close to the median of 68 across 102 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Vicryl group

    TIP hypospadias repair

    Procedure: TIP

  • Experimental
    PDS group

    TIP hypospadias repair

    Procedure: TIP

Interventions

  • ProcedureTIP

    TIP hypospadias repair

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What researchers measure

Primary outcomes

  1. complication rate

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

    Time frame: one year

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Study locations

1 site
  • Cairo University
    Cairo, 02, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06413901
Lead sponsor
Cairo University
Responsible party
Mohamed Abdelghany (lecturer, Cairo University) — Principal investigator
First posted
May 14, 2024
Start date
Sep 1, 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
May 14, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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