Double Dartos Versus Double Dartos Plus Byars' Flap in TIP Urethroplasty for Distal Hypospadias: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urethrocutaneous Fistula Formation
研究概览
简要总结
This randomized controlled trial evaluates the effect of adding Byar's flap in combination with double dartos flap coverage during tubularized incised plate (TIP) urethroplasty in children with distal hypospadias. The study compares surgical outcomes between two techniques: TIP urethroplasty with double dartos coverage alone versus TIP urethroplasty with double dartos plus Byar's flap reinforcement.
The primary outcome is the rate of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary outcomes include cosmetic outcome assessment and functional results using validated scoring systems.
Patients diagnosed with distal penile hypospadias were randomly assigned to either surgical group. All procedures were performed by an experienced pediatric surgeon under standardized operative conditions. Follow-up assessments were conducted over a 6-month postoperative period to evaluate early and intermediate surgical outcomes.
The objective of this study is to determine whether the addition of Byar's flap provides superior surgical outcomes compared to standard double dartos coverage in TIP urethroplasty.
详细描述
Hypospadias is a common congenital anomaly of the male urethra requiring surgical correction, with tubularized incised plate (TIP) urethroplasty being one of the most widely used techniques for distal forms. Despite advances in surgical methods, postoperative complications such as urethrocutaneous fistula, glans dehiscence, and meatal stenosis remain clinically significant.
Various tissue interposition techniques have been introduced to reduce complication rates, including the use of dartos flaps for neourethral coverage. The double dartos flap technique provides additional vascularized tissue support and has been associated with improved outcomes. However, in some cases, reinforcement with additional vascularized tissue such as Byar's flaps may further enhance healing and reduce complications.
This study was designed as a prospective randomized controlled trial conducted at Mardan Medical Complex. Pediatric patients diagnosed with distal penile hypospadias were enrolled and randomly allocated into two groups. Group A underwent TIP urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement. All surgeries were performed under standardized operative protocols by an experienced pediatric surgeon to minimize technical variability. Postoperative care was uniform across both groups. Patients were followed at regular intervals for a period of six months. The primary endpoint was the incidence of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary endpoints included cosmetic outcome and functional assessment of urinary stream.
The aim of this study was to evaluate whether the addition of Byar's flap to standard double dartos coverage provides a statistically and clinically significant improvement in surgical outcomes following TIP urethroplasty in distal hypospadias.
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
- None
盲法说明
Due to the nature of surgical interventions, masking was not feasible for participants or investigators.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male children aged 2-12 years Diagnosis of primary distal penile hypospadias (glanular, coronal, or subcoronal) No previous surgical repair for hypospadias Fit for general anesthesia as determined by preoperative assessment Written informed consent provided by parents or legal guardians -
排除标准
- •Midshaft or proximal hypospadias Severe chordee requiring staged repair Previous penile or hypospadias surgery Associated major genital anomalies Micropenis Bleeding disorders or systemic coagulopathies Unfit for general anesthesia
研究组 & 干预措施
Double Dartos Flap Group
Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage as a second-layer reinforcement over the neourethra for distal hypospadias repair.
干预措施: Double Dartos Flap Coverage (Procedure)
Double Dartos + Byar's Flap Group
Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage combined with Byar's flap reinforcement to provide additional vascularized tissue support over the neourethra in distal hypospadias repair.
干预措施: Byar's Flap + Double Dartos Flap (Procedure)
结局指标
主要结局
Urethrocutaneous Fistula Formation
时间窗: 6 months postoperatively
Incidence of urethrocutaneous fistula following tubularized incised plate (TIP) urethroplasty in distal hypospadias repair. Patients were assessed during scheduled follow-up visits over 6 months. Fistula formation was confirmed by clinical examination during postoperative evaluation.
次要结局
- HOSE Score (Cosmetic and Functional Outcome)(6 months postoperatively)
- Parental Satisfaction Score(6 months postoperatively)
- Operative Time(Intraoperative (during surgery))
研究者
Javaid Afridi
Assistant Professor of Pediatric Surgery
Mardan Medical Complex