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Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury (PREvsSPC)

Primary Purpose

Urethral Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Primary realignment
Suprapubic cystostomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Injury

Eligibility Criteria

1 Year - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male children less than 18 years presenting with pelvic fracture urethral injury

Exclusion Criteria:

  • Associated bladder neck injury.
  • Associated rectal injury.
  • Late presentation >2weeks since trauma.
  • History of previous urethral intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Primary realignment

    Suprapubic cystostomy

    Arm Description

    Outcomes

    Primary Outcome Measures

    The success rate after initial intervention (realignment or suprapubic cystostomy).
    The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram

    Secondary Outcome Measures

    The success rate of urethroplasty in both groups.
    The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.
    The need for urethroplasty in both groups.
    Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.

    Full Information

    First Posted
    March 6, 2018
    Last Updated
    April 30, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03468387
    Brief Title
    Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury
    Acronym
    PREvsSPC
    Official Title
    Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding: The success rate after initial intervention. The need for urethroplasty in the failed realignment group and cystostomy group. The success rate of urethroplasty in the failed realignment group and cystostomy group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urethral Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary realignment
    Arm Type
    Active Comparator
    Arm Title
    Suprapubic cystostomy
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Primary realignment
    Intervention Description
    Endoscopic realignment of rupture urethra over a urethral catheter
    Intervention Type
    Procedure
    Intervention Name(s)
    Suprapubic cystostomy
    Intervention Description
    Percutaneous cystostomy catheter will be inserted under sonographic guidance
    Primary Outcome Measure Information:
    Title
    The success rate after initial intervention (realignment or suprapubic cystostomy).
    Description
    The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram
    Time Frame
    3 months after initial intervention.
    Secondary Outcome Measure Information:
    Title
    The success rate of urethroplasty in both groups.
    Description
    The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.
    Time Frame
    3 months after urethroplasty.
    Title
    The need for urethroplasty in both groups.
    Description
    Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.
    Time Frame
    3 months after initial intervention

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male children less than 18 years presenting with pelvic fracture urethral injury Exclusion Criteria: Associated bladder neck injury. Associated rectal injury. Late presentation >2weeks since trauma. History of previous urethral intervention.

    12. IPD Sharing Statement

    Learn more about this trial

    Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury

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