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临床试验/CTRI/2026/03/106982
CTRI/2026/03/106982尚未招募3 期

Comparative Efficacy of Tunica Vaginalis Flap Versus Preputial Dartos Flap in Tubularized Incised Plate (TIP) Urethroplasty for Hypospadias: A Randomized Controlled Trial

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月15日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the postoperative complications of Tunica Vaginalis Flap (TVF) versus Preputial Dartos Flap (PDF) in Tubularized Incised Plate (TIP) urethroplasty for hypospadias.

研究概览

简要总结

Brief Summary

Hypospadias is a common congenital anomaly in males characterized by an abnormal location of the urethral meatus on the ventral surface of the penis. Surgical repair is required to restore normal urinary function, penile appearance, and long-term functional outcomes. Tubularized Incised Plate (TIP) urethroplasty is currently the most widely accepted surgical technique for distal and mid-penile hypospadias repair.

A key step in TIP urethroplasty is the placement of a vascularized tissue flap over the neourethra to reduce postoperative complications such as urethrocutaneous fistula, meatal stenosis, wound dehiscence, and poor cosmetic outcomes. Traditionally, the Preputial Dartos Flap (PDF) has been used for this purpose due to its easy availability and straightforward harvesting from the dorsal preputial tissue. However, limitations such as inadequate tissue in some cases, compromised vascularity, and higher risk of complications including fistula formation and meatal stenosis have been reported.

The Tunica Vaginalis Flap (TVF), harvested from the parietal layer of the tunica vaginalis of the testis, is a well-vascularized tissue that may provide superior coverage and improved healing of the neourethra. Although TVF has been increasingly used in hypospadias surgery, its routine use in primary TIP urethroplasty remains controversial because it requires additional surgical dissection and may be associated with scrotal morbidity.

This study aims to compare the efficacy and safety of tunica vaginalis flap versus preputial dartos flap as an intermediate layer in TIP urethroplasty through a randomized controlled trial. The primary objective is to compare postoperative complication rates, particularly urethrocutaneous fistula formation. Secondary outcomes include cosmetic appearance, functional urinary outcomes, and operative time.

This prospective randomized study will help generate evidence regarding the optimal tissue flap for neourethral coverage in hypospadias repair. The findings may contribute to improved surgical decision-making and better postoperative outcomes in children undergoing TIP urethroplasty.

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
1.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Age: Male patients aged between 1 and 25 years.
  • Well-developed prepuce, scrotum, and bilateral testes.
  • Urethral Plate Development: The urethral plate should be appropriately developed for the patient’s age.
  • Hypospadias Severity: Patients with distal and mid-shaft hypospadias are eligible for inclusion.
  • Informed Consent: Written informed consent must be provided by the parents or legal guardians of the patient.

排除标准

  • Genitourinary Malformations: Patients with genitourinary malformations or significant associated anomalies, such as bilateral undescended testes or bladder exstrophy.
  • Urethral Transection: Patients requiring urethral transection intraoperatively.
  • Staged Urethroplasty: Patients who require staged urethroplasty.
  • Previous Surgery: Patients with a history of previous surgery on the male genitalia.
  • Severe Coexisting Medical Conditions: Patients with severe coexisting medical conditions, including severe prematurity, chromosomal anomalies, or systemic diseases that may impair healing.

结局指标

主要结局

To compare the postoperative complications of Tunica Vaginalis Flap (TVF) versus Preputial Dartos Flap (PDF) in Tubularized Incised Plate (TIP) urethroplasty for hypospadias.

时间窗: 1 week(baseline),1 month ,3 month and 6 months

Postoperative complication includes-

时间窗: 1 week(baseline),1 month ,3 month and 6 months

Urethrocutaneous fistulas.

时间窗: 1 week(baseline),1 month ,3 month and 6 months

Wound dehiscence .

时间窗: 1 week(baseline),1 month ,3 month and 6 months

Prepuce-related complications.

时间窗: 1 week(baseline),1 month ,3 month and 6 months

Meatal stenosis.

时间窗: 1 week(baseline),1 month ,3 month and 6 months

次要结局

  • Cosmetic Outcomes: To assess the cosmetic outcomes using (Pediatric Penile Perception Score) and HOPE (Hypospadias Objective Penile Evaluation) score.(Functional Outcomes: To compare functional outcomes using uroflometry parameters in both early and up till 6-month follow-ups in patients who undergo TIP urethroplasty with TVF and PDF.)

研究者

发起方
AIIMS Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Saurabh Singh

AIIMS Patna

研究点 (1)

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