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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: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.

Project description:Surgical reduction of pelvic dislocation is a challenging procedure with poor long-term prognosis if reduction does not accurately restore natural morphology. The procedure often requires long fluoroscopic exposure times and trial-and-error to achieve accurate reduction. We report a method to automatically compute the target pose of dislocated bones in preoperative CT and provide 3D guidance of reduction using routine 2D fluoroscopy. A pelvic statistical shape model (SSM) and a statistical pose model (SPM) were formed from an atlas of 40 pelvic CT images. Multi-body bone segmentation was achieved by mapping the SSM to a preoperative CT via an active shape model. The target reduction pose for the dislocated bone is estimated by fitting the poses of undislocated bones to the SPM. Intraoperatively, multiple bones are registered to fluoroscopy images via 3D-2D registration to obtain 3D pose estimates from 2D images. The method was examined in three studies: (1) a simulation study of 40 CT images simulating a range of dislocation patterns; (2) a pelvic phantom study with controlled dislocation of the left innominate bone; (3) a clinical case study investigating feasibility in images acquired during pelvic reduction surgery. Experiments investigated the accuracy of registration as a function of initialization error (capture range), image quality (radiation dose and image noise), and field of view (FOV) size. The simulation study achieved target pose estimation with translational error of median 2.3 mm (1.4 mm interquartile range, IQR) and rotational error of 2.1° (1.3° IQR). 3D-2D registration yielded 0.3 mm (0.2 mm IQR) in-plane and 0.3 mm (0.2 mm IQR) out-of-plane translational error, with in-plane capture range of ±50 mm and out-of-plane capture range of ±120 mm. The phantom study demonstrated 3D-2D target registration error of 2.5 mm (1.5 mm IQR), and the method was robust over a large dose range, down to 5 [Formula: see text]Gy/frame (an order of magnitude lower than the nominal fluoroscopic dose). The clinical feasibility study demonstrated accurate registration with both preoperative and intraoperative radiographs, yielding 3.1 mm (1.0 mm IQR) projection distance error with robust performance for FOV ranging from 340 × 340 mm2 to 170 × 170 mm2 (at the image plane). The method demonstrated accurate estimation of the target reduction pose in simulation, phantom, and a clinical feasibility study for a broad range of dislocation patterns, initialization error, dose levels, and FOV size. The system provides a novel means of guidance and assessment of pelvic reduction from routinely acquired preoperative CT and intraoperative fluoroscopy. The method has the potential to reduce radiation dose by minimizing trial-and-error and to improve outcomes by guiding more accurate reduction of joint dislocations.

Project description:Prior high-trauma fractures identified through health services data are associated with low bone mineral density (BMD) and future fracture risk to the same extent as fractures without high-trauma. INTRODUCTION:Some have questioned the usefulness of distinguishing high-trauma fractures from low-trauma fractures. The aim of this study is to compare BMD measurements and risk of subsequent low-trauma fracture in patients with prior high- or low-trauma fractures. METHODS:Using a clinical BMD registry for the province of Manitoba, Canada, we identified women and men age 40 years or older with fracture records from linked population-based healthcare data. Age- and sex-adjusted BMD Z-scores and covariate-adjusted hazard ratios (HR) with 95% confidence intervals (CI) for incident fracture were studied in relation to prior fracture status, categorized as high-trauma if associated with external injury codes and low-trauma otherwise. RESULTS:The study population consisted of 64,428 women and men with no prior fracture (mean age 63.7 years), 858 with prior high-trauma fractures (mean age 65.1 years), and 14,758 with prior low-trauma fractures (mean age 67.2 years). Mean Z-scores for those with any prior high-trauma fracture were significantly lower than in those without prior fracture (P?<?0.001) and similar to those with prior low-trauma fracture. Median observation time for incident fractures was 8.8 years (total 729,069 person-years). Any prior high-trauma fracture was significantly associated with increased risk for incident major osteoporotic fracture (MOF) (adjusted HR 1.31, 95% CI 1.08-1.59) as was prior low-trauma fracture (adjusted HR 1.55, 95% CI 1.47-1.63), and there was no significant difference between the two groups (prior trauma versus low-trauma fracture P?=?0.093). A similar pattern was seen when incident MOF was studied in relation to prior hip fracture or prior MOF, or when the outcome was incident hip fracture or any incident fracture. CONCLUSIONS:High-trauma and low-trauma fractures showed similar relationships with low BMD and future fracture risk. This supports the inclusion of high-trauma fractures in clinical assessment for underlying osteoporosis and in the evaluation for intervention to reduce future fracture risk.

Project description:Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated). We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating on parameters that have more direct policy implications, these potentially automated approaches allow methodological standardization across similar comparativeness effectiveness studies.

Project description:There is an upward trend in facial injuries following changes in population pattern, increasing industrialization and urbanization, hence maxillofacial trauma is becoming a burden and a leading medical problem in emergency rooms worldwide. This study was performed to evaluate the pattern of maxillofacial fractures, associated injuries, and treatment used at Jai Prakash Narayan Apex Trauma Center (JPNATC), All India Institute of Medical Sciences (AIIMS), New Delhi, India, between January 2007 and June 2010. The study provides basis for establishment of trauma as major etiology of maxillofacial injuries and planning for preventive strategies. A retrospective study of patients seen and treated at JPNATC, AIIMS, New Delhi, between January 2007 and June 2010 was performed. Data extracted from patient records included etiology, age, sex, types and sites of fractures, treatment modality, and concomitant injuries. There were 795 fractures of the maxillofacial skeleton and 86 concomitant injuries from 542 patients. Road traffic accident (RTA) (56.8%) was the most common etiologic factor, followed by falls (22.3%) and fights (18.5%). The age range was from 3 to 75 years (mean, 34.7 years) with a peak incidence in the third decade with a male-to-female ratio of 3.7:1. The most common location of maxillofacial fractures was the mandible 615 (77%) and middle third 180 (23%). With regard to mandibular fractures, the body (29.6%) was the most common site, followed by the angle (24.4%), ramus (19.5%), dentoalveolar (14.6%), symphysis (11.0%), condyle (0.8%) while in the middle third, the nasal bone (36.7%) was the most common, followed by zygomatic bone (27.8), Lefort II (14.4), Lefort I (7.8%), dentoalveolar (10.0%), and Lefort III (3.3%). Majority of the patients were treated by open reduction and internal fixation (70.6). Concomitant injuries were 84 (10.8%) with orthopedic injuries accounting for the majority (63.9%). Head injury was associated in 16.3% of cases. RTA was the major etiologic factor of maxillofacial injuries in our setting and the young adult males were the main victims. Henceforth, establishment of regionalized, efficient, and focused trauma centers in various parts of the country particularly for acute trauma should be emphasized. Also, the laws regarding the precautions such as seat belts, speed limits, and traffic rules must be observed strictly to reduce the incidence of RTA.

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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