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临床试验/NCT06705699
NCT06705699尚未招募不适用

Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias

Assiut University0 个研究点目标入组 60 人开始时间: 2024年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
urethrocutaneous fistula

研究概览

简要总结

The aim of this research is to compare the surgical outcomes of urethral mobilization and the Mathieu technique in treating distal penile hypospadias. The study will evaluate complication rates such as fistula formation and meatal stenosis, assess functional outcomes related to urinary stream quality, and analyze cosmetic results including the appearance of the neomeatus. Ultimately, the goal is to provide evidence-based guidance for choosing the most appropriate technique to optimize surgical outcomes and patient satisfaction.

详细描述

Hypospadias is a common congenital malformation of the male genitalia, characterized by the abnormal positioning of the urethral meatus along the ventral surface of the penis . It affects approximately 1 in every 200 male births and is most frequently observed in its distal form, where the urethral opening is located near the glans . Surgical correction of hypospadias is necessary to ensure proper urinary function, achieve a cosmetically acceptable appearance, and prevent future complications such as chordee or abnormal curvature of the penis . There are several surgical techniques available for repairing distal penile hypospadias, each with its own advantages and drawbacks. Among these, the Mathieu technique and the urethral mobilization technique are two commonly employed approaches.

The Mathieu technique, first introduced in 1932, uses a perimeatal-based flap to reconstruct the urethra. It is a reliable and well-established method that is associated with a relatively low rate of complications, such as urethrocutaneous fistula and meatal stenosis. However, one of the main limitations of the Mathieu technique is the creation of a rounded or horizontal meatus, which is often considered less cosmetically pleasing compared to the more natural slit-like meatus formed by other techniques. Despite this drawback, the Mathieu technique remains a popular choice for surgeons, particularly in cases where the urethral plate is well-developed and no additional ventral curvature correction is required.

The urethral mobilization technique, on the other hand, involves the proximal mobilization and distal advancement of the native urethra to the tip of the glans without using a preputial flap. This approach can be especially beneficial for boys who have already undergone circumcision, as it does not rely on the availability of a preputial skin flap. Studies suggest that urethral mobilization results in satisfactory functional outcomes and a lower incidence of certain complications, such as meatal stenosis and postoperative fistula formation. Furthermore, it is considered a straightforward procedure that avoids extensive tissue dissection, making it an appealing option for selected cases of distal hypospadias.

While both techniques have demonstrated satisfactory outcomes, there is a need for a comprehensive comparison to evaluate their effectiveness and safety profiles. Existing literature suggests that urethral mobilization results in lower complication rates compared to the Mathieu technique in specific clinical settings. Additionally, a study by reported that the Mathieu technique with an incision of the urethral plate showed significantly fewer complications, including meatal stenosis and fistula formation, compared to the tubularized incised-plate (TIP) technique, further demonstrating the variability in outcomes based on surgical approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

data analyst

入排标准

年龄范围
6 Months 至 7 Years(Child)
性别
Male
接受健康志愿者
否

入选标准

  • •Male patients aged 6 months to 7 years.
  • •Diagnosed with distal penile hypospadias (coronal, or subcoronal types).
  • •Mild to no chordee present (curvature <30°).
  • •No associated with severe genital anomalies.

排除标准

  • •Patients with proximal hypospadias (midshaft, penoscrotal, or perineal).
  • •Presence of significant chordee requiring separate corrective procedures.
  • •Hypoplastic or poorly developed urethral plate that is unsuitable for surgical repair.
  • •Previous hypospadias repair surgery.
  • •Patients with severe comorbidities or conditions that could increase the risk of surgery (e.g., severe cardiac anomalies).

研究组 & 干预措施

Urethral Mobilization Technique

Experimental

• Description: Involves mobilizing the urethral tube proximally and advancing it distally to the glans. The urethra is repositioned and sutured at the neomeatal position.

干预措施: Urethral mobilisation (Procedure)

Mathieu Technique

Experimental

• Description: Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.

干预措施: Mathieu (Procedure)

结局指标

主要结局

urethrocutaneous fistula

时间窗: 1 month

Absence of urethrocutaneous fistula formation • Postoperative complication rates, including urethrocutaneous fistula formation, meatal stenosis, wound infection, hematoma, and retraction of the neomeatus.

meatal stenosis

时间窗: 2 months

absence of meatal stenosis

wound infection

时间窗: 1 week

absence of wound infection

hematoma

时间窗: 3 days

absence of hematoma

neomeatus retraction

时间窗: 3 months

absence of retraction of the neomeatus.

次要结局

  • quality of the urinary stream(2 months)
  • cosmetic(3 months)
  • shape(3 months)
  • position of the neomeatus(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Elnoby Mohamed Abdelhameed

assistant lecturer

Assiut University

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