Comparing Outcomes of Two Repair Methods with or without Extra Tissue Layer in Hypospadias Surgery

Comparing Outcomes of Tubularized Incised Plate Urethroplasty in Hypospadias with or without De-epithelialized Dorsal Preputial Dartos Flap as an Intervening Layer- A Pilot Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084730

Enrollment

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tubularized Incised Plate Urethroplasty in Hypospadias with De-epithelialized Dorsal Preputial Dartos Flap as an Intervening Layer.: A feeding tube of appropriate size is inserted, and

Eligibility

Inclusion criteria

Inclusion criteria: Children of age 1 to 12 years. Children with hypospadias who are eligible for single stage Tubularized Incised Plate Urethroplasty. Urethral plate width more than 6mm. Children who have not undergone circumcision. Children who have not undergone prior hypospadias repair. Children whose parents are willing to provide informed written consent.

Exclusion criteria

Exclusion criteria: Children with hypospadias with chordee. Children requiring staged procedure, onlay flap repair.

Design outcomes

Primary

Measure	Time frame
To compare the combined incidence of postoperative complications i.e., urethrocutaneous fistula and glans dehiscence in Tubularized Incised Plate urethroplasty with or without the use of de-epithelialized dorsal preputial dartos flap as an intervening layer at 6 months follow-up after surgery.Timepoint: 6 months	—

Secondary

Measure	Time frame
1.To compare the aforementioned groups for the following outcomes: a.Intra operative outcomes Duration of surgery (in minutes) Intra operative blood loss (in millilitres) Injury to dorsal neurovascular bundle b.Postoperative outcomes Surgical site infection Skin necrosis. Duration of dressing Duration of catheterisation Duration of hospital stay 2.To evaluate the cosmetic appearance of penis & meatal orientation using Hypospadias Objective Penile Evaluation (HOPE) score at 6 month follow-up after surgery. Timepoint: Intraoperative outcomes are noted at the time of surgery Postoperative outcomes are noted at 2 weeks after surgery. Cosmetic evaluation is done at 6 months after surgery.	—

Measure

Time frame

1.To compare the aforementioned groups for the following outcomes: a.Intra operative outcomes Duration of surgery (in minutes) Intra operative blood loss (in millilitres) Injury to dorsal neurovascular bundle b.Postoperative outcomes Surgical site infection Skin necrosis. Duration of dressing Duration of catheterisation Duration of hospital stay 2.To evaluate the cosmetic appearance of penis & meatal orientation using Hypospadias Objective Penile Evaluation (HOPE) score at 6 month follow-up after surgery. Timepoint: Intraoperative outcomes are noted at the time of surgery Postoperative outcomes are noted at 2 weeks after surgery. Cosmetic evaluation is done at 6 months after surgery.

—

Countries

India

Contacts

Public ContactUppaluri Jahnavi

All India Institute of Medical Sciences

drshasankaiims06@gmail.com9873542072

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026