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Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee (DuckettvDFPF)

Primary Purpose

Hypospadias, Penoscrotal, Chordee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transverse preputial island flap (Duckett's technique)
Double-faced preputial flap (DFPF)
Sponsored by
dr. Muhammad Abdelhafez Mahmoud, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias, Penoscrotal focused on measuring Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair

Eligibility Criteria

6 Months - 14 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Uncircumcised male patients with penoscrotal hypospadias,
  • rudimentary urethral plate
  • with moderate-to-severe chordee and
  • no history of previous repair

Exclusion Criteria:

  • circumcised patients,
  • patients with other types of hypospadias such as glanular or distal shaft or
  • with mild chordee corrected after penile degloving,
  • recurrent hypospadias, or
  • lost to follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Transverse preputial island flap (Duckett's technique)

    Double-faced preputial flap (DFPF)

    Arm Description

    72 patients (Group I) with penoscrotal hypospadias with chordee

    72 patients (Group II) with penoscrotal hypospadias with chordee

    Outcomes

    Primary Outcome Measures

    Urethrocutaneous fistula (number & percent)
    Urethrocutaneous fistula
    Meatal stenosis (number & percent)
    Meatal stenosis
    Urethral stricture (number & percent)
    Urethral stricture

    Secondary Outcome Measures

    Penile rotation (number & percent)
    Penile rotation
    Urine stream (in caliber)
    Urine stream
    Urine stream (in meters)
    Urine stream
    Micturition time (in seconds)
    Micturition time
    Follow-up period (in months)
    Follow-up period

    Full Information

    First Posted
    October 9, 2020
    Last Updated
    October 21, 2020
    Sponsor
    dr. Muhammad Abdelhafez Mahmoud, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04605068
    Brief Title
    Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
    Acronym
    DuckettvDFPF
    Official Title
    Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (Actual)
    Primary Completion Date
    September 2019 (Actual)
    Study Completion Date
    March 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    dr. Muhammad Abdelhafez Mahmoud, MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypospadias, Penoscrotal, Chordee
    Keywords
    Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantInvestigator
    Masking Description
    Double masking (Participant, Investigator)
    Allocation
    Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transverse preputial island flap (Duckett's technique)
    Arm Type
    Active Comparator
    Arm Description
    72 patients (Group I) with penoscrotal hypospadias with chordee
    Arm Title
    Double-faced preputial flap (DFPF)
    Arm Type
    Active Comparator
    Arm Description
    72 patients (Group II) with penoscrotal hypospadias with chordee
    Intervention Type
    Procedure
    Intervention Name(s)
    Transverse preputial island flap (Duckett's technique)
    Intervention Type
    Procedure
    Intervention Name(s)
    Double-faced preputial flap (DFPF)
    Primary Outcome Measure Information:
    Title
    Urethrocutaneous fistula (number & percent)
    Description
    Urethrocutaneous fistula
    Time Frame
    2 years
    Title
    Meatal stenosis (number & percent)
    Description
    Meatal stenosis
    Time Frame
    2 years
    Title
    Urethral stricture (number & percent)
    Description
    Urethral stricture
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Penile rotation (number & percent)
    Description
    Penile rotation
    Time Frame
    3 years
    Title
    Urine stream (in caliber)
    Description
    Urine stream
    Time Frame
    3 years
    Title
    Urine stream (in meters)
    Description
    Urine stream
    Time Frame
    3 years
    Title
    Micturition time (in seconds)
    Description
    Micturition time
    Time Frame
    3 years
    Title
    Follow-up period (in months)
    Description
    Follow-up period
    Time Frame
    5 years

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Male children with penoscrotal hypospadias with chordee
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Uncircumcised male patients with penoscrotal hypospadias, rudimentary urethral plate with moderate-to-severe chordee and no history of previous repair Exclusion Criteria: circumcised patients, patients with other types of hypospadias such as glanular or distal shaft or with mild chordee corrected after penile degloving, recurrent hypospadias, or lost to follow-up.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed M Shahin, MD
    Organizational Affiliation
    Al-Azhar New Damietta University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
    IPD Sharing Time Frame
    March 2020 till indefinitely
    IPD Sharing Access Criteria
    after the article became accepted and available online.

    Learn more about this trial

    Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee

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