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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.

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.

SUBMITTER: Moses RA

PROVIDER: S-EPMC6127553 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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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.

Moses Rachel A RA Selph John Patrick JP Voelzke Bryan B BB Piotrowski Joshua J Eswara Jairam R JR Erickson Bradley A BA Gupta Shubham S Dmochowski Roger R RR Johnsen Niels V NV Shridharani Anand A Blaschko Sarah D SD Elliott Sean P SP Schwartz Ian I Harris Catherine R CR Borawski Kristy K Figler Bradley D BD Osterberg E Charles EC Burks Frank N FN Bihrle William W Miller Brandi B Santucci Richard A RA Breyer Benjamin N BN Flynn Brian B Higuchi Ty T Kim Fernando J FJ Broghammer Joshua A JA Presson Angela P AP Myers Jeremy B JB

Translational andrology and urology 20180801 4

<h4>Background</h4>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.<h4>Methods</h4>A prospective cohort trial was designed to compare outcomes between ...[more]

PMID: 30211041

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Project description:BackgroundTo evaluate erectile and sexual function after pelvic fracture urethral injury (PFUI) by performing a retrospective review of a large multi-center database. We hypothesized that most men will have erectile dysfunction (ED) and poor sexual function following PFUI, which will remain after posterior urethroplasty.MethodsUsing the Trauma and Urologic Reconstructive Networks of Surgeons (TURNS) database, we identified PFUI patients undergoing posterior urethroplasty. We excluded patients with incomplete demographic, surgical and/or questionnaire data. Sexual Health Inventory of Men (SHIM), Male Sexual Health Questionnaire (MSHQ), and subjective changes in penile curvature were collected before urethroplasty surgery and at follow-up. We performed descriptive statistics for erectile and ejaculatory function using STATA v12.ResultsWe identified 92 men meeting inclusion criteria; median age was 41.7 years and BMI was 26.5. The mechanism of injury was blunt in all patients, and average distraction defect length was 2.3 cm (SD 1.0 cm). In the 38 patients who completed both pre and post-operative SHIM questionnaires, the mean SHIM score was 10.5 (SD 7.0), with 63% having severe ED (SHIM <12). The median follow-up was 5.6 months and the mean post-operative SHIM was 9.3 (SD 6.5), with 68% having severe ED. The mean change in SHIM score was -1.18 (SD 6.29) with 6 (16%) patients reporting de novo ED (≥5 point decrease in score). Of the men with pre-operative MSHQ data, 46/74 (62.1%) had difficulty with ejaculation, 25/35 (71%) had change in penile length, and 6/33 (18%) reported penile curvature. In men with post-operative MSHQ, 19/44 (43%) expressed difficulty with ejaculation, 23/32 (72%) had change in penile length, and 9/33 (27%) reported penile curvature.ConclusionsThere is a high rate of severe ED, both following PFUI and remaining after posterior urethroplasty. Additionally, rates of ejaculatory difficulty and patient perceived changes in penile length and curvature underscore the complex nature of the impact of these injuries on sexual function beyond simple erectile function.

Project description:PurposesSurgical reduction of pelvic fracture is a challenging procedure, and accurate restoration of natural morphology is essential to obtaining positive functional outcome. The procedure often requires extensive preoperative planning, long fluoroscopic exposure time, and trial-and-error to achieve accurate reduction. We report a multi-body registration framework for reduction planning using preoperative CT and intraoperative guidance using routine 2D fluoroscopy that could help address such challenges.MethodThe framework starts with semi-automatic segmentation of fractured bone fragments in preoperative CT using continuous max-flow. For reduction planning, a multi-to-one registration is performed to register bone fragments to an adaptive template that adjusts to patient-specific bone shapes and poses. The framework further registers bone fragments to intraoperative fluoroscopy to provide 2D fluoroscopy guidance and/or 3D navigation relative to the reduction plan. The framework was investigated in three studies: (1) a simulation study of 40 CT images simulating three fracture categories (unilateral two-body, unilateral three-body, and bilateral two-body); (2) a proof-of-concept cadaver study to mimic clinical scenario; and (3) a retrospective clinical study investigating feasibility in three cases of increasing severity and accuracy requirement.ResultsSegmentation of simulated pelvic fracture demonstrated Dice coefficient of 0.92±0.06. Reduction planning using the adaptive template achieved 2-3 mm and 2-3° error for the three fracture categories, significantly better than planning based on mirroring of contralateral anatomy. 3D-2D registration yielded ~2 mm and 0.5° accuracy, providing accurate guidance with respect to the preoperative reduction plan. The cadaver study and retrospective clinical study demonstrated comparable accuracy: ~0.90 Dice coefficient in segmentation, ~3 mm accuracy in reduction planning, and ~2 mm accuracy in 3D-2D registration.ConclusionThe registration framework demonstrated planning and guidance accuracy within clinical requirements in both simulation and clinical feasibility studies for a broad range of fracture-dislocation patterns. Using routinely acquired preoperative CT and intraoperative fluoroscopy, the framework could improve the accuracy of pelvic fracture reduction, reduce radiation dose, and could integrate well with common clinical workflow without the need for additional navigation systems.

Dataset Information

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.

Publications

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.

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