Mohamed M Shahin
Cairo, 34517, Egypt
NCT Number: NCT04636476
To present update & experience in management of congenital penile curvature complex.
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Notify Me2 year–10 year
Male
Interventional
Not applicable
Cairo, 34517, Egypt
Type of study: prospective study
Review of literature:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
Time frame: 5 years
Clockwise rotation of the penis (number & percent)
Time frame: 5 years
Counterlockwise rotation of the penis (number & percent)
Time frame: 5 years
Ventral Curvature of the penis (number & percent)
Time frame: 5 years
Dorsal Curvature of the penis (number & percent)
Time frame: 5 years
Lateral Curvature of the penis (number & percent)
Time frame: 5 years
Age of the patients (years)
Time frame: 1 day (day of surgery)
Operative time (minutes)
Time frame: 1 week
Hospital stay period (days)
Time frame: 5 years
Follow-up period (months)
Time frame: 5 years
Functional impairment (number & percent)
Time frame: 5 years
Aesthetic impairment (number & percent)
Time frame: 5 years
Residual curvature > 10° (number & percent)
Time frame: 5 years
Residual rotation > 10° (number & percent)
Time frame: 5 years
Post-operative paresthesia (number & percent)
Time frame: 5 years
Skin ischemia (number & percent)
Time frame: 5 years
Hematoma (number & percent)
Time frame: 5 years
Dressing soaked with blood (number & percent)
dr. Muhammad Abdelhafez Mahmoud, MD
Other
Acronym: Al-AzharCPCC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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