Clinical trial NCT04636476: One Stage Correction of Congenital Penile Curvature Complex
Official title: One Stage Correction of Congenital Penile Curvature Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Anomaly
Chordee
Curvature of Penis
Torsion of the Penis
Keywords: Congenital penile curvature;
Penile rotation;
Dorsal dartos flap;
Complex anomaly
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 56
Sex: MALE
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential Assignment Prospective cohort study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clockwise rotation
timeFrame: 5 years
measure: Counterlockwise rotation
timeFrame: 5 years
measure: Ventral Curvature
timeFrame: 5 years
measure: Dorsal Curvature
timeFrame: 5 years
measure: Lateral Curvature
timeFrame: 5 years
measure: Age
timeFrame: 5 years
measure: Operative time
timeFrame: 1 day (day of surgery)
measure: Post-operative hospital stay
timeFrame: 1 week
measure: Post-operative follow-up period
timeFrame: 5 years
Secondary outcomes:
measure: Functional impairment
timeFrame: 5 years
measure: Aesthetic impairment
timeFrame: 5 years
measure: Residual curvature > 10°
timeFrame: 5 years
measure: Residual rotation > 10°
timeFrame: 5 years
measure: Post-operative paresthesia
timeFrame: 5 years
measure: Skin ischemia
timeFrame: 5 years
measure: Hematoma
timeFrame: 5 years
measure: Dressing soaked with blood
timeFrame: 5 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed M Shahin
Study officials:
affiliation: Al-Azhar New Damietta University
name: Mohamed M Shahin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: