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

Not Applicable

Completed

• Conditions: Hypospadias Repair
• Interventions: Procedure: TIP

• Registration Number: NCT06413901
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

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)

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDS group	TIP	TIP hypospadias repair
Vicryl group	TIP	TIP hypospadias repair

Primary Outcome Measures

Name	Time	Method
complication rate	one year	urethrocutaneous fistula, wound infection, wound dehiscence, overall complications, and reoperation rates

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt