One Stage Correction of Congenital Penile Curvature Complex

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: 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.

Official Title
-----------------
One Stage Correction of Congenital Penile Curvature Complex

Conditions
-----------------
Congenital Anomaly, Chordee, Curvature of Penis, Torsion of the Penis

Intervention / Treatment
-----------------
* Procedure: Modified Nesbit's procedure and dorsal dartos flap


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Sequential Assignment Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Modified Nesbit technique followed by dorsal dartos flap<br>Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion | Procedure: Modified Nesbit's procedure and dorsal dartos flap<br>* Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clockwise rotation | Clockwise rotation of the penis (number & percent) | 5 years | 
| Counterlockwise rotation | Counterlockwise rotation of the penis (number & percent) | 5 years | 
| Ventral Curvature | Ventral Curvature of the penis (number & percent) | 5 years | 
| Dorsal Curvature | Dorsal Curvature of the penis (number & percent) | 5 years | 
| Lateral Curvature | Lateral Curvature of the penis (number & percent) | 5 years | 
| Age | Age of the patients (years) | 5 years | 
| Operative time | Operative time (minutes) | 1 day (day of surgery) | 
| Post-operative hospital stay | Hospital stay period (days) | 1 week | 
| Post-operative follow-up period | Follow-up period (months) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional impairment | Functional impairment (number & percent) | 5 years | 
| Aesthetic impairment | Aesthetic impairment (number & percent) | 5 years | 
| Residual curvature > 10° | Residual curvature > 10° (number & percent) | 5 years | 
| Residual rotation > 10° | Residual rotation > 10° (number & percent) | 5 years | 
| Post-operative paresthesia | Post-operative paresthesia (number & percent) | 5 years | 
| Skin ischemia | Skin ischemia (number & percent) | 5 years | 
| Hematoma | Hematoma (number & percent) | 5 years | 
| Dressing soaked with blood | Dressing soaked with blood (number & percent) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital penile curvature;, Penile rotation;, Dorsal dartos flap;, Complex anomaly