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OpenTrials
Completed

NCT Number: NCT05960123

Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

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Key information

Conditions

Hypospadias Complication,Postoperative Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Postoperative Complications Urogenital Abnormalities Urogenital Diseases

Age range

6 month–14 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Daboos

Cairo, Select, 115678, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

Exclusion criteria

  • recurrent cases Proximal; hypospadias

Treatment and study plan

Tubularized Incised Plate (TIP) urethroplasty

Procedure

tubularization of urethral plate with or without spongioplasty

Primary outcomes

  1. Urethrocutaneous fistula

    Time frame: 12 months

    Rate of fistula

  2. meatal stenosis

    Time frame: 12 months

    Rate of metal stenosis

  3. glans dehiscence

    Time frame: 12 months

    Rate of glans dehiscence

Other outcomes

  1. Cosmetic results

    Time frame: 12 months

    Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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