Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
Condition: Hypospadias, Penoscrotal; Chordee
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      The purpose of this study is to compare the outcomes and complications of the transverse
      preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF)
      for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical
      functional evaluation by estimated urine flow.
    

Detailed description: 
      Type of study: RCT

      Review of literature:

        -  Different modalities of urethroplasty for repair of proximal hypospadias with chordee
           (two-stage repair, one-stage repair, flap, graft).

        -  Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..

        -  Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a
           prospective randomized controlled study conducted at pediatric surgery department,
           Al-Houssain & New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020,
           on 144 male patients with penoscrotal hypospadias with chordee. Patients will be
           investigated by routine laboratory tests for fitness for surgery. All of them will
           undergo one-stage repair using either of 2 techniques of tubularized preputial flap;
           Duckett's versus DFPF. Written informed consent will be obtained from parents of all
           participants in the study.

      Institutes of the study:

      A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo
      and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period
      of 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 procedures and the aim of the study
      will be clearly explained to the patient and the family. A written informed consent will be
      obtained before enrollment of the patients into the study. The family refusal to give consent
      for one-stage repair is respected but does not deprive the patient from getting surgical care
      by two-stage repair.

      Preoperative preparation:

      All patients will be subjected to history taking, clinical examination, and necessary
      laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests,
      Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic
      30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated
      randomization table) into two equal groups, each will include 72 patients; Group I will
      undergo transverse preputial island flap (Duckett's technique) and Group II will undergo
      double-faced preputial flap (DFPF). Both techniques will be done by all members of the
      surgical team equally.

      Follow-up:

      Patients will be followed-up at OPD.

      Statistical Analysis:

      Data were collected using a data collecting sheets (annexes) and were analyzed using the
      statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows,
      IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation
      (SD), range, and average and categorical variables were expressed as frequency count &
      percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A
      two-sided p-value < 0.05 was considered statistically significant.

      Discussion:

      It will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias
      with chordee. 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
      estimated urine caliber and micturition time. At the end, the investigators will conclude the
      reconstructive technique that gives the better results and least morbidity.
    

Intervention name(s): Transverse preputial island flap (Duckett's technique); Double-faced preputial flap (DFPF)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 144 patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Penoscrotal Hypospadias; Chordee; Tubularized Double-Faced Preputial Flap; Duckett's Urethroplasty; One-Stage Repair