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

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ClinicalTrials.gov Identifier: NCT03468387
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Osama, Assiut University

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:

  1. The success rate after initial intervention.
  2. The need for urethroplasty in the failed realignment group and cystostomy group.
  3. The success rate of urethroplasty in the failed realignment group and cystostomy group.

Condition or disease Intervention/treatment Phase
Urethral Injury Procedure: Primary realignment Procedure: Suprapubic cystostomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Primary realignment Procedure: Primary realignment
Endoscopic realignment of rupture urethra over a urethral catheter

Active Comparator: Suprapubic cystostomy Procedure: Suprapubic cystostomy
Percutaneous cystostomy catheter will be inserted under sonographic guidance




Primary Outcome Measures :
  1. The success rate after initial intervention (realignment or suprapubic cystostomy). [ Time Frame: 3 months after initial intervention. ]
    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 :
  1. The success rate of urethroplasty in both groups. [ Time Frame: 3 months after urethroplasty. ]
    The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.

  2. The need for urethroplasty in both groups. [ Time Frame: 3 months after initial intervention ]
    Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Responsible Party: Mohamed Osama, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03468387     History of Changes
Other Study ID Numbers: URSP
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Wounds and Injuries
Hip Fractures
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries