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.

Autor: Moses RA; Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USA., Selph JP; Department of Urology, University of Alabama at Birmingham, Birmingham, AL, USA., Voelzke BB; Department of Urology, Harborview Medical Center, University of Washington, Seattle, WA, USA., Piotrowski J; Department of Urology, Medical College of Wisconsin, Milwaukee, WI, USA., Eswara JR; Division of Urology, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA., Erickson BA; Department of Urology, University of Iowa, Iowa City, IA, USA., Gupta S; Department of Urology, University of Kentucky, Lexington, KY, USA., Dmochowski RR; Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA., Johnsen NV; Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA., Shridharani A; Department of Urology, University of Tennessee College of Medicine, Chattanooga, TN, USA., Blaschko SD; Division of Urology, Alameda Health System, Oakland, CA, USA., Elliott SP; Division of Urology, Department of Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USA., Schwartz I; Division of Urology, Department of Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USA., Harris CR; Santa Clara Valley Medical Center, San Jose, CA, USA., Borawski K; Department of Urology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA., Figler BD; Department of Urology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA., Osterberg EC 3rd; Department of Surgery, University of Texas, Dell Medical School, Austin, TX, USA., Burks FN; Department of Urology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA., Bihrle W 3rd; Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Miller B; Department of Urology, Detroit Medical Center, Detroit, MI, USA., Santucci RA; Department of Urology, Detroit Medical Center, Detroit, MI, USA., Breyer BN; Department of Urology, University of California-San Francisco, San Francisco, CA, USA., Flynn B; Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USA., Higuchi T; Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USA., Kim FJ; Department of Surgery (Urology), University of Colorado School of Medicine, Aurora, CO, USA., Broghammer JA; Department of Urology, University of Kansas Medical Center, Kansas City, Kansas, USA., Presson AP; Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USA., Myers JB; Division of Urology, Department of Surgery, University of Utah, Salt Lake City, UT, USA.
Jazyk: angličtina
Zdroj: Translational andrology and urology [Transl Androl Urol] 2018 Aug; Vol. 7 (4), pp. 512-520.
DOI: 10.21037/tau.2017.11.07
Abstrakt: 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.
Competing Interests: Conflicts of Interest: This study is registered on clinicaltrials.gov (identifier NCT03195179).
Databáze: MEDLINE