Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04636476 |
Other study ID # |
Al-AzharCPCC |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2015 |
Est. completion date |
May 2020 |
Study information
Verified date |
November 2020 |
Source |
Al-Azhar University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To present update & experience in management of congenital penile curvature complex.
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.