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

Assiut University

Status: Unknown

Conditions: Urethral Injury

Treatments: Procedure: Suprapubic cystostomy; Procedure: Primary realignment

Study type: Interventional

Funder types: Other

Identifiers

NCT03468387

URSP

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 1 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Primary realignment

Active Comparator group

Treatment:

Procedure: Primary realignment

Suprapubic cystostomy

Active Comparator group

Treatment:

Procedure: Suprapubic cystostomy