NCT03468387

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

March 6, 2018

Last Update Submit

April 30, 2018

Conditions

Urethral Injury

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months after initial intervention.

Secondary Outcomes (2)

  • The success rate of urethroplasty in both groups.

    3 months after urethroplasty.

  • The need for urethroplasty in both groups.

    3 months after initial intervention

Study Arms (2)

Primary realignment

ACTIVE COMPARATOR
Procedure: Primary realignment

Suprapubic cystostomy

ACTIVE COMPARATOR
Procedure: Suprapubic cystostomy

Interventions

Primary realignmentPROCEDURE

Endoscopic realignment of rupture urethra over a urethral catheter

Primary realignment
Suprapubic cystostomyPROCEDURE

Percutaneous cystostomy catheter will be inserted under sonographic guidance

Suprapubic cystostomy

Eligibility Criteria

Age1 Year - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cystostomy

Intervention Hierarchy (Ancestors)

OstomySurgical Procedures, OperativeUrinary DiversionUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 16, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 1, 2018

Record last verified: 2018-04