In Children with Hypospadias, Comparing Two Tissue Covering Methods in Surgery and Their Effect on Healing and Complications

Comparative Efficacy of Tunica Vaginalis Flap Versus Preputial Dartos Flap in Tubularized Incised Plate (TIP) Urethroplasty for Hypospadias: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106982

Enrollment

Registered

2026-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N489- Disorder of penis, unspecified

Interventions

Intervention1: TIP urethroplasty with Dartos Fascia Flap: Intraoperative findings including external urethral meatus (EUM), urethral plate characteristics (length, width, and development), stretched

Eligibility

Inclusion criteria

Inclusion criteria: Age: Male patients aged between 1 and 25 years. Well-developed prepuce, scrotum, and bilateral testes. Urethral Plate Development: The urethral plate should be appropriately developed for the patient s age. Hypospadias Severity: Patients with distal and mid-shaft hypospadias are eligible for inclusion. Informed Consent: Written informed consent must be provided by the parents or legal guardians of the patient.

Exclusion criteria

Exclusion criteria: Genitourinary Malformations: Patients with genitourinary malformations or significant associated anomalies, such as bilateral undescended testes or bladder exstrophy. Urethral Transection: Patients requiring urethral transection intraoperatively. Staged Urethroplasty: Patients who require staged urethroplasty. Previous Surgery: Patients with a history of previous surgery on the male genitalia. Severe Coexisting Medical Conditions: Patients with severe coexisting medical conditions, including severe prematurity, chromosomal anomalies, or systemic diseases that may impair healing.

Design outcomes

Primary

Measure	Time frame
To compare the postoperative complications of Tunica Vaginalis Flap (TVF) versus Preputial Dartos Flap (PDF) in Tubularized Incised Plate (TIP) urethroplasty for hypospadias. Postoperative complication includes- Urethrocutaneous fistulas. Wound dehiscence . Prepuce-related complications. Meatal stenosis. Timepoint: 1 week(baseline),1 month ,3 month and 6 months	—

Secondary

Measure	Time frame
Cosmetic Outcomes: To assess the cosmetic outcomes using (Pediatric Penile Perception Score) and HOPE (Hypospadias Objective Penile Evaluation) score. Functional Outcomes: To compare functional outcomes using uroflometry parameters in both early and up till 6-month follow-ups in patients who undergo TIP urethroplasty with TVF and PDF. Operative Time and Surgical Considerations: To compare the operative time required for the TVF and PDF procedures Timepoint: 1 week,1 month , 3 months,6 months	—

Measure

Time frame

Cosmetic Outcomes: To assess the cosmetic outcomes using (Pediatric Penile Perception Score) and HOPE (Hypospadias Objective Penile Evaluation) score. Functional Outcomes: To compare functional outcomes using uroflometry parameters in both early and up till 6-month follow-ups in patients who undergo TIP urethroplasty with TVF and PDF. Operative Time and Surgical Considerations: To compare the operative time required for the TVF and PDF procedures Timepoint: 1 week,1 month , 3 months,6 months

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Countries

India

Contacts

Public ContactVipin Chandra

AIIMS Patna

ccchandra2001@gmail.com8442840839

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026