One Stage Correction of Congenital Penile Curvature Complex (Al-AzharCPCC)
Primary Purpose
Congenital Anomaly, Chordee, Curvature of Penis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified Nesbit's procedure and dorsal dartos flap
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Anomaly focused on measuring Congenital penile curvature;, Penile rotation;, Dorsal dartos flap;, Complex anomaly
Eligibility Criteria
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.
Sites / Locations
- Mohamed M Shahin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Modified Nesbit technique followed by dorsal dartos flap
Arm Description
Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion
Outcomes
Primary Outcome Measures
Clockwise rotation
Clockwise rotation of the penis (number & percent)
Counterlockwise rotation
Counterlockwise rotation of the penis (number & percent)
Ventral Curvature
Ventral Curvature of the penis (number & percent)
Dorsal Curvature
Dorsal Curvature of the penis (number & percent)
Lateral Curvature
Lateral Curvature of the penis (number & percent)
Age
Age of the patients (years)
Operative time
Operative time (minutes)
Post-operative hospital stay
Hospital stay period (days)
Post-operative follow-up period
Follow-up period (months)
Secondary Outcome Measures
Functional impairment
Functional impairment (number & percent)
Aesthetic impairment
Aesthetic impairment (number & percent)
Residual curvature > 10°
Residual curvature > 10° (number & percent)
Residual rotation > 10°
Residual rotation > 10° (number & percent)
Post-operative paresthesia
Post-operative paresthesia (number & percent)
Skin ischemia
Skin ischemia (number & percent)
Hematoma
Hematoma (number & percent)
Dressing soaked with blood
Dressing soaked with blood (number & percent)
Full Information
NCT ID
NCT04636476
First Posted
November 13, 2020
Last Updated
November 13, 2020
Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
1. Study Identification
Unique Protocol Identification Number
NCT04636476
Brief Title
One Stage Correction of Congenital Penile Curvature Complex
Acronym
Al-AzharCPCC
Official Title
One Stage Correction of Congenital Penile Curvature Complex
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta & Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.
Preoperative preparation:
Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist & pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 is considered statistically significant.
Discussion:
It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). The results obtained from this study will be compared between both group and with those reported in the literature. Also, it will focus on results, complications, their management, and clinical evaluation by noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Anomaly, Chordee, Curvature of Penis, Torsion of the Penis
Keywords
Congenital penile curvature;, Penile rotation;, Dorsal dartos flap;, Complex anomaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sequential Assignment Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Nesbit technique followed by dorsal dartos flap
Arm Type
Other
Arm Description
Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion
Intervention Type
Procedure
Intervention Name(s)
Modified Nesbit's procedure and dorsal dartos flap
Intervention Description
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
Primary Outcome Measure Information:
Title
Clockwise rotation
Description
Clockwise rotation of the penis (number & percent)
Time Frame
5 years
Title
Counterlockwise rotation
Description
Counterlockwise rotation of the penis (number & percent)
Time Frame
5 years
Title
Ventral Curvature
Description
Ventral Curvature of the penis (number & percent)
Time Frame
5 years
Title
Dorsal Curvature
Description
Dorsal Curvature of the penis (number & percent)
Time Frame
5 years
Title
Lateral Curvature
Description
Lateral Curvature of the penis (number & percent)
Time Frame
5 years
Title
Age
Description
Age of the patients (years)
Time Frame
5 years
Title
Operative time
Description
Operative time (minutes)
Time Frame
1 day (day of surgery)
Title
Post-operative hospital stay
Description
Hospital stay period (days)
Time Frame
1 week
Title
Post-operative follow-up period
Description
Follow-up period (months)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Functional impairment
Description
Functional impairment (number & percent)
Time Frame
5 years
Title
Aesthetic impairment
Description
Aesthetic impairment (number & percent)
Time Frame
5 years
Title
Residual curvature > 10°
Description
Residual curvature > 10° (number & percent)
Time Frame
5 years
Title
Residual rotation > 10°
Description
Residual rotation > 10° (number & percent)
Time Frame
5 years
Title
Post-operative paresthesia
Description
Post-operative paresthesia (number & percent)
Time Frame
5 years
Title
Skin ischemia
Description
Skin ischemia (number & percent)
Time Frame
5 years
Title
Hematoma
Description
Hematoma (number & percent)
Time Frame
5 years
Title
Dressing soaked with blood
Description
Dressing soaked with blood (number & percent)
Time Frame
5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male children from 2-10 years old with CPCC with normal urethral meatus
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Shahin, MD,PhD
Organizational Affiliation
Al-Azhar New Damietta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed M Shahin
City
Cairo
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
IPD Sharing Time Frame
from now indefinitely
IPD Sharing Access Criteria
after the article became accepted and available online.
Learn more about this trial
One Stage Correction of Congenital Penile Curvature Complex
We'll reach out to this number within 24 hrs