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

Urethral Injury Clinical Trial

— PREvsSPC  

Official title:

Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03468387
• Other study ID #: URSP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Urethral Injury
• Wounds and Injuries

Intervention

Procedure:
• Primary realignment
Endoscopic realignment of rupture urethra over a urethral catheter
• Suprapubic cystostomy
Percutaneous cystostomy catheter will be inserted under sonographic guidance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The success rate of urethroplasty in both groups.	The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy.	3 months after urethroplasty.
Secondary	The need for urethroplasty in both groups.	Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy.	3 months after initial intervention