Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Urethral diverticulum
研究概览
简要总结
Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps.
This study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.
详细描述
Type of study: prospective RCT
Review of literature:
- Different previous techniques for the repair of various levels of penile shaft hypospadias with chordee.
- Demonstration of two different well-established techniques for repair of anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
- Disadvantages of two-stage urethroplasty or technique as transverse inner preputial onlay island flap that involves dissection of the flap from its dorsal preputial tissue (as it affects the flap vascularity).
- Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it combines the benefits of vascularized pedicled flap, provides better functional and cosmetic results, and low complication rate).
This study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of urethroplasty; double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.
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
- Double (Participant, Investigator)
盲法说明
2 (Participant, Investigator) 2 masking (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Young male pediatric patients diagnosed as anterior, mid-penile, or posterior penile hypospadias
- •with shallow and narrow urethral plate measuring less than 6 millimeters,
- •without or with mild penile curvature of less than 30º after degloving of the penis.
排除标准
- •Patients with wide urethral plate suitable for tubularized incised plate (TIP) urethroplasty,
- •other types of hypospadias as penoscrotal, scrotal, perineal hypospadias,
- •patients with moderate or severe penile curvature,
- •recurrent cases, and
- •operations done by other surgeons
结局指标
主要结局
Urethral diverticulum
时间窗: 3 years
Urethral diverticulum in number of cases \&percentage
Urethrocutaneous fistula
时间窗: 3 years
Urethrocutaneous fistula in number of cases \&percentage
Glannular dehiscence
时间窗: 3 years
Glannular dehiscence in number of cases \&percentage
Flap necrosis
时间窗: 3 years
Flap necrosis in number of cases \&percentage
Penile rotation
时间窗: 3 years
Penile rotation in number of cases \&percentage
次要结局
- Meatal shape(3 years)
- Urinary stream direction(3 years)
- Erection(3 years)
- Meatal location(3 years)
- Fistula(3 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Faculty of Medicine, Al-Azhar University
Al-Azhar University