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临床试验/CTRI/2025/04/084730
CTRI/2025/04/084730尚未招募2 期

Comparing Outcomes of Tubularized Incised Plate Urethroplasty in Hypospadias with or without De-epithelialized Dorsal Preputial Dartos Flap as an Intervening Layer- A Pilot Randomized Controlled Trial

UPPALURI JAHNAVI1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
To compare the combined incidence of postoperative complications i.e., urethrocutaneous fistula and glans dehiscence in Tubularized Incised Plate urethroplasty with or without the use of de-epithelialized dorsal preputial dartos flap as an intervening layer at 6 months follow-up after surgery.

研究概览

简要总结

Hypospadiasis one of the most common genitourinary birth defects, occurring in around 1 in300 male births. Surgery is the sole treatment option for hypospadias. The mostcommon and baffling problem that occurs after hypospadias repair is theurethrocutaneous fistula (UCF), and its treatment is very challenging. Hence tolessen the incidence of this complication various techniques using vascularisedsoft tissue flaps in between neourethra and skin as an intervening layer arebeing practiced. Although various advantages and disadvantages of theintervening layer have been reported, definitive evidence to establish itssuperiority in reducing post-hypospadias repair complications remains lacking.To address this, we designed a Pilot Randomized Controlled Trial to evaluateand compare the surgical and cosmetic outcomes of Tubularized Incised Plate (TIP) urethroplasty in hypospadias with orwithout de-epithelialized dorsal preputial dartos flap as an intervening layer.The objectives of the study are to compare the combined incidence ofpostoperative complications i.e., urethrocutaneous fistula and glans dehiscenceand to compare the intra operative outcomes, post operative outcomes along withcosmetic appearance using Hypospadias Objective Penile Evaluation (HOPE) score inTubularized Incised Plate urethroplasty with or without the use ofde-epithelialized dorsal preputial dartos flap as an intervening layer at 6months follow-up after surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
Male

入选标准

  • Children of age 1 to 12 years.
  • Children with hypospadias who are eligible for single stage Tubularized Incised Plate Urethroplasty.
  • Urethral plate width more than 6mm.
  • Children who have not undergone circumcision.
  • Children who have not undergone prior hypospadias repair.
  • Children whose parents are willing to provide informed written consent.

排除标准

  • Children with hypospadias with chordee.
  • Children requiring staged procedure, onlay flap repair.

结局指标

主要结局

To compare the combined incidence of postoperative complications i.e., urethrocutaneous fistula and glans dehiscence in Tubularized Incised Plate urethroplasty with or without the use of de-epithelialized dorsal preputial dartos flap as an intervening layer at 6 months follow-up after surgery.

时间窗: 6 months

次要结局

  • 1.To compare the aforementioned groups for the following outcomes:(a.Intra operative outcomes)

研究者

发起方
UPPALURI JAHNAVI
申办方类型
Other [PRIMARY INVESTIGATOR]

研究点 (1)

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