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

Not Applicable

• Conditions: Urethral Injury
• Interventions: Procedure: Primary realignment; Procedure: Suprapubic cystostomy

• Registration Number: NCT03468387
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01
• Study Start: 2018-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary realignment	Primary realignment	-
Suprapubic cystostomy	Suprapubic cystostomy	-

Primary Outcome Measures

Name	Time	Method
The success rate after initial intervention (realignment or suprapubic cystostomy).	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

Name	Time	Method
The need for urethroplasty in both groups.	3 months after initial intervention	Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.
The success rate of urethroplasty in both groups.	3 months after urethroplasty.	The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.