One Stage Correction of Congenital Penile Curvature Complex
Condition: Congenital Anomaly; Chordee; Curvature of Penis; Torsion of the Penis
MeSH terms: Congenital Abnormalities
Study type: Interventional

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.
    

Intervention name(s): Modified Nesbit's procedure and dorsal dartos flap
Intervention type(s): Procedure
Intervention description(s): Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
Intervention model: Single Group Assignment
Intervention model description: Sequential Assignment Prospective cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congenital penile curvature;; Penile rotation;; Dorsal dartos flap;; Complex anomaly