One Stage Correction of Congenital Penile Curvature Complex
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Counterlockwise rotation
Study Overview
Brief Summary
To present update & experience in management of congenital penile curvature complex.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 10 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Counterlockwise rotation
Time Frame: 5 years
Counterlockwise rotation of the penis (number \& percent)
Ventral Curvature
Time Frame: 5 years
Ventral Curvature of the penis (number \& percent)
Clockwise rotation
Time Frame: 5 years
Clockwise rotation of the penis (number \& percent)
Dorsal Curvature
Time Frame: 5 years
Dorsal Curvature of the penis (number \& percent)
Lateral Curvature
Time Frame: 5 years
Lateral Curvature of the penis (number \& percent)
Age
Time Frame: 5 years
Age of the patients (years)
Operative time
Time Frame: 1 day (day of surgery)
Operative time (minutes)
Post-operative hospital stay
Time Frame: 1 week
Hospital stay period (days)
Post-operative follow-up period
Time Frame: 5 years
Follow-up period (months)
Secondary Outcomes
- Residual curvature > 10°(5 years)
- Residual rotation > 10°(5 years)
- Post-operative paresthesia(5 years)
- Skin ischemia(5 years)
- Hematoma(5 years)
- Dressing soaked with blood(5 years)
- Functional impairment(5 years)
- Aesthetic impairment(5 years)
Investigators
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar university, Faculty of Medicine
Al-Azhar University