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

NCT ID: NCT03468387

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Urethral Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary realignment

Group Type ACTIVE_COMPARATOR

Primary realignment

Intervention Type PROCEDURE

Endoscopic realignment of rupture urethra over a urethral catheter

Suprapubic cystostomy

Group Type ACTIVE_COMPARATOR

Suprapubic cystostomy

Intervention Type PROCEDURE

Percutaneous cystostomy catheter will be inserted under sonographic guidance

Interventions

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Primary realignment

Endoscopic realignment of rupture urethra over a urethral catheter

Intervention Type PROCEDURE

Suprapubic cystostomy

Percutaneous cystostomy catheter will be inserted under sonographic guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Osama

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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URSP

Identifier Type: -

Identifier Source: org_study_id

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