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Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?

Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07086963
Enrollment
584
Registered
2025-07-25
Start date
2023-01-02
Completion date
2025-08-08
Last updated
2025-07-25

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

Conditions

Hypospadias

Keywords

Grafted TIP, Tabularized Incised Plate

Brief summary

This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery. the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.

Detailed description

This prospective, randomized study included all patients who presented with primary hypospadias without chordee. investigators aimed to investigate whether grafted inlay patch with Tabularized Incised Plate repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices. Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. Patients were randomized into two groups using sealed envelopes labeled as group 1 or group 2, selected by the operating theater chief nurse. An independent statistician approved the sample size. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery. The first visit occurred on the 5th postoperative day. On 2nd week, the patients attended for catheter removal after complete healing. Calibration was performed one week after catheter removal, followed by monthly for the first six months, with HOSE scoring conducted after six months.

Interventions

PROCEDURERepaired with standard TIP repair as described by Snodgrass

Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF

PROCEDURERepaired with TIP with GIP using preputial graft

The urethral plate was deeply incised from the glans tip, extending downwards beyond the junction between the plate and the hypospadiac meatus Graft fixation The graft was then spread to cover the raw area and fixed to the edges of the urethral plate. Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF

Sponsors

Mohammad Daboos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft

Eligibility

Sex/Gender
MALE
Age
6 Months to 120 Months
Healthy volunteers
No

Inclusion criteria

* Primary hypospadias candidates for one-stage repair * Uncircumcised cases * Pediatric age group * Patients with regular follow up

Exclusion criteria

* The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair * Small glans \< 11mm * glanular hypospadias

Design outcomes

Primary

MeasureTime frameDescription
Surgical outcomes6 monthscomplications rates
cosmetic results6 monthscosmetic results with Hypospadias Objective Scoring Evaluation.
Functional outcomes6 monthsUrine Flow from the neourethra

Countries

Egypt

Contacts

Primary ContactMohammad Daboos, Prof
daboosmohammad@gmail.com01007578148
Backup ContactMohammad Negm, Prof
yww4178@gmail.com01550087767

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026