Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: 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
- 144
- 主要终点
- Urethrocutaneous fistula (number & percent)
研究概览
简要总结
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.
详细描述
Type of study: RCT
Review of literature:
- Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).
- Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..
- Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain & New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. 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 tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.
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
Double masking (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Uncircumcised male patients with penoscrotal hypospadias,
- •rudimentary urethral plate
- •with moderate-to-severe chordee and
- •no history of previous repair
排除标准
- •circumcised patients,
- •patients with other types of hypospadias such as glanular or distal shaft or
- •with mild chordee corrected after penile degloving,
- •recurrent hypospadias, or
- •lost to follow-up.
结局指标
主要结局
Urethrocutaneous fistula (number & percent)
时间窗: 2 years
Urethrocutaneous fistula
Meatal stenosis (number & percent)
时间窗: 2 years
Meatal stenosis
Urethral stricture (number & percent)
时间窗: 3 years
Urethral stricture
次要结局
- Follow-up period (in months)(5 years)
- Penile rotation (number & percent)(3 years)
- Urine stream (in caliber)(3 years)
- Urine stream (in meters)(3 years)
- Micturition time (in seconds)(3 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery
Al-Azhar University