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临床试验/CTRI/2025/03/082271
CTRI/2025/03/082271尚未招募4 期

Outcome Analysis of Tubularized Incised Plate Urethroplasty & Urethral Advancement with Glanuloplasty for Distal Hypospadias in Pediatric Patients of a Tertiary Care Center in Nagpur: A Prospective Open-label Randomized trial.

Dr Nilesh Nagdeve1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月21日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare the outcomes in terms of success rate and complication, following tubularised incised plate urethroplasty and Urethral Advancement Glansplasty techniques for distal hypospadias repair in the pediatric population

研究概览

简要总结

Hypospadias a common congenital anomaly affecting the male genitourinary system. It is characterized by the abnormal placement of the urethral meatus on the ventral surface of the penis . It occurs in approximately 1 in 250 live male births worldwide, with potentially higher prevalence rates in certain populations, including India (1). This anomaly not only affects physical appearance but also has implications for urinary function and psychological well-being.

Hypospadias is categorised according to the location of urethral meatus in various subcategories of which distal hypospadias is more common position of meatus. There are more than 200 reconstructive procedures described for hypospadias repair with their pros and cons. However, over the last thirty years, the tabularised incised plate urethroplasty (TIPU) described by Snodgrass has gain a popularity and is one of the most commonly performed procedure now a days.  The procedure  creates a neourethra by longitudinally incising and tabularising the urethral plate.(2) The problems with TIPU are comparatively high rates of stricture and fistula following surgery.(3)  Urethral advancement with Glanuloplasty (UAG) is another surgical technique in which the native urethral meatus along with  the bulbous and pendulous segments urethra is advanced to the tip of the glans penis.(4) First described by Beck, the procedure has undergone many modifications over the years.(5) The advantages of this procedure are less risk of post-operative fistula and stricture formation.However, there is only one study which compares the outcome following these procedures.(6)

In order to fill the gap in the literature, this prospective randomized trial is planned with the following aim and objectives

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 1.Children under 18 years of age with distal hypospadias 2.Patients with minimal chordee on clinical examination, and less than 20 degrees measured during artificial erection test intraoperatively.

排除标准

  • 1.Re-do surgeries for failed hypospadias repair 2.Parents not consenting 3.Glandular hypospadias 4.Patients with Disorders of Sexual Development.

结局指标

主要结局

To compare the outcomes in terms of success rate and complication, following tubularised incised plate urethroplasty and Urethral Advancement Glansplasty techniques for distal hypospadias repair in the pediatric population

时间窗: Patient will be followed up in the outpatient clinic 15 days, 1 month ,and 3 months after operation.

次要结局

  • 1.To compare the cosmetic outcomes following TIPU & UAG for distal hypospadias.(2.To compare parental response regarding the postoperative course & cosmesis following these two operative techniques)

研究者

发起方
Dr Nilesh Nagdeve
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nilesh Nagdeve

AIIMS Nagpur

研究点 (1)

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