One Stage Correction of Congenital Penile Curvature Complex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
To present update & experience in management of congenital penile curvature complex.
详细描述
Type of study: prospective study
Review of literature:
- Different modalities of urethroplasty for correction of CPCC without hypospadias (Nesbit, modified Nesbit, dorsal dartos flap, combined plication-incision CPI, suture fixation to pubic bone).
- Merits of modified Nesbit technique accompanied by dorsal dartos flap for one-stage correction of CPCC without hypospadias.
This is a prospective study conducted at pediatric surgery department, New Damietta & Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.
Institutes of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •2 to 10 years old boys
- •with congenital curvature complex of the penis
- •with normally situated urethral meatus.
- •The various degrees of penile curvature ranged between 30° - 90° associated with 30° - 90° penile rotation
排除标准
- •Boys with CPCC with abnormal urethral meatus as hypospadias or epispadias, or
- •with the range of angle degree of penile curvature less than 30° associated with less than 30° penile rotation or
- •with acquired penile curvature or
- •having an isolated lesion.
研究组 & 干预措施
Modified Nesbit technique followed by dorsal dartos flap
Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion
干预措施: Modified Nesbit's procedure and dorsal dartos flap (Procedure)
结局指标
主要结局
Operative time
时间窗: 1 day (day of surgery)
Operative time (minutes)
Post-operative hospital stay
时间窗: 1 week
Hospital stay period (days)
Counterlockwise rotation
时间窗: 5 years
Counterlockwise rotation of the penis (number \& percent)
Ventral Curvature
时间窗: 5 years
Ventral Curvature of the penis (number \& percent)
Lateral Curvature
时间窗: 5 years
Lateral Curvature of the penis (number \& percent)
Clockwise rotation
时间窗: 5 years
Clockwise rotation of the penis (number \& percent)
Dorsal Curvature
时间窗: 5 years
Dorsal Curvature of the penis (number \& percent)
Age
时间窗: 5 years
Age of the patients (years)
Post-operative follow-up period
时间窗: 5 years
Follow-up period (months)
次要结局
- Dressing soaked with blood(5 years)
- Residual curvature > 10°(5 years)
- Residual rotation > 10°(5 years)
- Post-operative paresthesia(5 years)
- Skin ischemia(5 years)
- Hematoma(5 years)
- Functional impairment(5 years)
- Aesthetic impairment(5 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar university, Faculty of Medicine
Al-Azhar University