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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypospadias Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vicryl group

TIP hypospadias repair

Group Type EXPERIMENTAL

TIP

Intervention Type PROCEDURE

TIP hypospadias repair

PDS group

TIP hypospadias repair

Group Type EXPERIMENTAL

TIP

Intervention Type PROCEDURE

TIP hypospadias repair

Interventions

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TIP

TIP hypospadias repair

Intervention Type PROCEDURE

Eligibility Criteria

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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)