One Stage Correction of Congenital Penile Curvature Complex

Congenital Anomaly Clinical Trial

— Al-AzharCPCC  

Official title:

One Stage Correction of Congenital Penile Curvature Complex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636476
• Other study ID #: Al-AzharCPCC
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chordee
• Congenital Abnormalities
• Congenital Anomaly
• Curvature of Penis
• Torsion of the Penis

Intervention

Procedure:
• Modified Nesbit's procedure and dorsal dartos flap
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion

Locations

Country	Name	City	State
Egypt	Mohamed M Shahin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
dr. Muhammad Abdelhafez Mahmoud, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clockwise rotation	Clockwise rotation of the penis (number & percent)	5 years
Primary	Counterlockwise rotation	Counterlockwise rotation of the penis (number & percent)	5 years
Primary	Ventral Curvature	Ventral Curvature of the penis (number & percent)	5 years
Primary	Dorsal Curvature	Dorsal Curvature of the penis (number & percent)	5 years
Primary	Lateral Curvature	Lateral Curvature of the penis (number & percent)	5 years
Primary	Age	Age of the patients (years)	5 years
Primary	Operative time	Operative time (minutes)	1 day (day of surgery)
Primary	Post-operative hospital stay	Hospital stay period (days)	1 week
Primary	Post-operative follow-up period	Follow-up period (months)	5 years
Secondary	Functional impairment	Functional impairment (number & percent)	5 years
Secondary	Aesthetic impairment	Aesthetic impairment (number & percent)	5 years
Secondary	Residual curvature > 10°	Residual curvature > 10° (number & percent)	5 years
Secondary	Residual rotation > 10°	Residual rotation > 10° (number & percent)	5 years
Secondary	Post-operative paresthesia	Post-operative paresthesia (number & percent)	5 years
Secondary	Skin ischemia	Skin ischemia (number & percent)	5 years
Secondary	Hematoma	Hematoma (number & percent)	5 years
Secondary	Dressing soaked with blood	Dressing soaked with blood (number & percent)	5 years