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An American Association for the Surgery of Trauma (AAST) prospective multi-center research protocol: outcomes of urethral realignment versus suprapubic cystostomy after pelvic fracture urethral injury
- Source :
- Translational Andrology and Urology
- Publication Year :
- 2018
-
Abstract
- Background: Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial primary urethral realignment (PR) after PFUI decreases the incidence of urethral obstruction and the need for subsequent urethral procedures. We present methodology for a prospective cohort study analyzing the outcomes of PR versus suprapubic cystostomy tube (SPT) after PFUI. Methods: A prospective cohort trial was designed to compare outcomes between PR (group 1) and SPT placement (group 2). Centers are assigned to a group upon entry into the study. All patients will undergo retrograde attempted catheter placement; if this fails a cystoscopy exam is done to confirm a complete urethral disruption and attempt at gentle retrograde catheter placement. If catheter placement fails, group 1 will undergo urethral realignment and group 2 will undergo SPT. The primary outcome measure will be the rate of urethral obstruction preventing atraumatic passage of a flexible cystoscope. Secondary outcome measures include: subsequent urethral interventions, post-injury complications, urethroplasty complexity, erectile dysfunction (ED) and urinary incontinence rates. Results: Prior studies demonstrate PR is associated with a 15% to 50% reduction in urethral obstruction. Ninety-six men (48 per treatment group) are required to detect a 15% treatment effect (80% power, 0.05 significance level, 20% loss to follow up/death rate). Busy trauma centers treat complete PFUI approximately 1–6 times per year, thus our goal is to recruit 25 trauma centers and enroll patients for 3 years with a goal of 100 or more total patients with complete urethral disruption. Conclusions: The proposed prospective multi-institutional cohort study should determine the utility of acute urethral realignment after PFUI.
- Subjects :
- urethroplasty
medicine.medical_specialty
Urology
medicine.medical_treatment
Urethroplasty
030232 urology & nephrology
Urinary incontinence
03 medical and health sciences
0302 clinical medicine
medicine
Prospective cohort study
Suprapubic cystostomy
medicine.diagnostic_test
business.industry
urethral injury
030208 emergency & critical care medicine
Cystoscopy
primary realignment
medicine.disease
Surgery
Erectile dysfunction
Reproductive Medicine
Genitourinary trauma
pelvic fracture urethral injury (PFUI)
Pelvic fracture
Original Article
medicine.symptom
business
Cohort study
Subjects
Details
- ISSN :
- 22234691
- Volume :
- 7
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Translational andrology and urology
- Accession number :
- edsair.doi.dedup.....8bf77df2997428e45dd03fc5c1afa8aa