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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Hypospadias Repair

Treatments

Procedure: TIP

Study type

Interventional

Funder types

Other

Identifiers

NCT06413901
N-421-2023

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

Male

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

69 participants in 2 patient groups

Vicryl group
Experimental group
Description:
TIP hypospadias repair
Treatment:
Procedure: TIP
PDS group
Experimental group
Description:
TIP hypospadias repair
Treatment:
Procedure: TIP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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