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

TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures: A Prospective, Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Hypospadias Repair
• Intervention / Treatment: Procedure: TIP

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vicryl group; TIP hypospadias repair	Procedure: TIP; TIP hypospadias repair
Experimental: PDS group; TIP hypospadias repair	Procedure: TIP; TIP hypospadias repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate	urethrocutaneous fistula, wound infection, wound dehiscence, overall complications, and reoperation rates	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: N-421-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No