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Effect of Adding Byar's Flap to Double Dartos Coverage in TIP Urethroplasty for Distal Hypospadias: A Randomized Trial

Double Dartos Versus Double Dartos Plus Byars' Flap in TIP Urethroplasty for Distal Hypospadias: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07525570
Acronym
DD-TIP-BF
Enrollment
120
Registered
2026-04-13
Start date
2024-01-10
Completion date
2025-07-10
Last updated
2026-04-13

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

Conditions

Distal Penile Hypospadias (Disorder), Hypospadias

Keywords

TIP urethroplasty, Tubularized incised plate, Pediatric urology, Byar's flap, Dartos flap, Hypospadias repair, Urethrocutaneous fistula, Pediatric surgery, Surgical outcomes, Randomized controlled trial

Brief summary

This randomized controlled trial evaluates the effect of adding Byar's flap in combination with double dartos flap coverage during tubularized incised plate (TIP) urethroplasty in children with distal hypospadias. The study compares surgical outcomes between two techniques: TIP urethroplasty with double dartos coverage alone versus TIP urethroplasty with double dartos plus Byar's flap reinforcement. The primary outcome is the rate of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary outcomes include cosmetic outcome assessment and functional results using validated scoring systems. Patients diagnosed with distal penile hypospadias were randomly assigned to either surgical group. All procedures were performed by an experienced pediatric surgeon under standardized operative conditions. Follow-up assessments were conducted over a 6-month postoperative period to evaluate early and intermediate surgical outcomes. The objective of this study is to determine whether the addition of Byar's flap provides superior surgical outcomes compared to standard double dartos coverage in TIP urethroplasty.

Detailed description

Hypospadias is a common congenital anomaly of the male urethra requiring surgical correction, with tubularized incised plate (TIP) urethroplasty being one of the most widely used techniques for distal forms. Despite advances in surgical methods, postoperative complications such as urethrocutaneous fistula, glans dehiscence, and meatal stenosis remain clinically significant. Various tissue interposition techniques have been introduced to reduce complication rates, including the use of dartos flaps for neourethral coverage. The double dartos flap technique provides additional vascularized tissue support and has been associated with improved outcomes. However, in some cases, reinforcement with additional vascularized tissue such as Byar's flaps may further enhance healing and reduce complications. This study was designed as a prospective randomized controlled trial conducted at Mardan Medical Complex. Pediatric patients diagnosed with distal penile hypospadias were enrolled and randomly allocated into two groups. Group A underwent TIP urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement. All surgeries were performed under standardized operative protocols by an experienced pediatric surgeon to minimize technical variability. Postoperative care was uniform across both groups. Patients were followed at regular intervals for a period of six months. The primary endpoint was the incidence of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary endpoints included cosmetic outcome and functional assessment of urinary stream. The aim of this study was to evaluate whether the addition of Byar's flap to standard double dartos coverage provides a statistically and clinically significant improvement in surgical outcomes following TIP urethroplasty in distal hypospadias.

Interventions

PROCEDUREDouble Dartos Flap Coverage

A vascularized dartos fascia flap is harvested and used as a second-layer coverage over the neourethra following tubularized incised plate (TIP) urethroplasty to reduce postoperative complications such as urethrocutaneous fistula.

PROCEDUREByar's Flap + Double Dartos Flap

Byar's flaps are created from preputial skin and combined with double dartos flap coverage to reinforce the neourethral repair after tubularized incised plate (TIP) urethroplasty in distal hypospadias.

Sponsors

Javaid Afridi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Due to the nature of surgical interventions, masking was not feasible for participants or investigators.

Intervention model description

Participants were randomly assigned to one of two parallel groups receiving different surgical techniques for distal hypospadias repair. Group A underwent tubularized incised plate (TIP) urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement.

Eligibility

Sex/Gender
MALE
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

Male children aged 2-12 years Diagnosis of primary distal penile hypospadias (glanular, coronal, or subcoronal) No previous surgical repair for hypospadias Fit for general anesthesia as determined by preoperative assessment Written informed consent provided by parents or legal guardians -

Exclusion criteria

Midshaft or proximal hypospadias Severe chordee requiring staged repair Previous penile or hypospadias surgery Associated major genital anomalies Micropenis Bleeding disorders or systemic coagulopathies Unfit for general anesthesia \-

Design outcomes

Primary

MeasureTime frameDescription
Urethrocutaneous Fistula Formation6 months postoperativelyIncidence of urethrocutaneous fistula following tubularized incised plate (TIP) urethroplasty in distal hypospadias repair. Patients were assessed during scheduled follow-up visits over 6 months. Fistula formation was confirmed by clinical examination during postoperative evaluation.

Secondary

MeasureTime frameDescription
HOSE Score (Cosmetic and Functional Outcome)6 months postoperativelyCosmetic and functional outcome was assessed using the Hypospadias Objective Scoring Evaluation (HOSE) system at 6-month follow-up. Scores were compared between both surgical groups.
Parental Satisfaction Score6 months postoperativelyParental satisfaction with surgical outcome was assessed using a standardized satisfaction scale at 6-month follow-up. Scores were analyzed between both groups.
Operative TimeIntraoperative (during surgery)Total operative time was recorded from skin incision to completion of wound closure in minutes for each surgical group.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026