Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?
NCT ID: NCT07086963
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
584 participants
INTERVENTIONAL
2023-01-02
2025-08-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
Repaired with standard Tubularized incised plate repair as described by Snodgrass
Repaired 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
Group 2
Repaired with Grafted Tubularized incised plate repair using preputial graft
Repaired 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
Interventions
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Repaired 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
Repaired 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
Eligibility Criteria
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Inclusion Criteria
* Uncircumcised cases
* Pediatric age group
* Patients with regular follow up
Exclusion Criteria
* Small glans \< 11mm
* glanular hypospadias
6 Months
120 Months
MALE
No
Sponsors
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Mohammad Daboos
OTHER
Responsible Party
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Mohammad Daboos
Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.
Principal Investigators
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Mohammad Daboos
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University
Locations
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Mohammad Daboos
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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SVU/SUR011/4/22/12/519
Identifier Type: -
Identifier Source: org_study_id
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