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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 prep
• Процедура 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

Первичные конечные точки

• Surgical outcomes [Срок оценки: 6 months]
• cosmetic results [Срок оценки: 6 months]
• Functional outcomes [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mohammad Daboos — Cairo

Публикации

• Negm MA, Abdelrasheed AA, Daboos M, Khedre MM, Abdelrahman MF, Abo-Halawa NAE, Ibrahim IA, Shehata MA. Is dorsal inlay graft (DIG) with TIP repair superior to TIP alone for primary hypospadias? A randomized clinical trial. BMC Pediatr. 2026 Jan 26;26(1):62. doi: 10.1186/s12887-025-06247-7. PMID 41588344

Идентификаторы

NCT: NCT07086963 · SVU/SUR011/4/22/12/519

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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