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Background: Morbidly obese patients undergoing bariatric surgery have high rates of gastroesophageal reflux and are often treated with acid-reducing medications (ARM) such as proton pump inhibitors or H2-blockers. The objective of this study was to evaluate the effect of bariatric procedures on the utilization of ARM. We analyzed data from the clinical registry of the Michigan Bariatric Surgery Collaborative on 35,477 patients undergoing bariatric surgery between January 2006 and October 2012 who completed both baseline and 1-year follow-up surveys. Procedures included laparoscopic adjustable gastric banding (LAGB, n=2,627), Roux-en-Y gastric bypass (RYGB, n=6,410), sleeve gastrectomy (SG, n=1,567), and biliopancreatic diversion with duodenal switch (BPD/DS, n=162)., Methods: Rates of ARM at 1 year by procedure type were compared using logistic regression analysis. Models were adjusted for patient characteristics, baseline co-morbidities, weight loss, and hiatal hernia repair., Results: Overall ARM use at baseline was 37.7% and declined to 29.6% at 1 year after bariatric surgery. The proportion of patients starting an ARM at 1 year when they were not using one at baseline by procedure was LAGB (13.9%), RYGB (19.2%), SG (21.6%), and BPD/DS (26.7%). The proportion of patients discontinuing an ARM at 1 year when they were using one at baseline by procedure was LAGB (55.6%), RYGB (56.2%), SG (37.3%), and BPD/DS (42.1%). Compared with LAGB on multivariable analysis, the likelihood of ARM use at 1 year was higher for SG (OR 1.70, 95% CI 1.45-1.99) and BDP/DS (OR 1.53, CI .97-2.40) but not different for RYGB (OR 1.02, CI .90-1.16)., Conclusion: Overall ARM use decreases after bariatric surgery; however, it is not uniform and depends on procedure type. SG is a significant predictor for ARM use at 1 year., (Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Although resident involvement has been shown to be safe for most procedures, the impact of residents on outcomes after complex laparoscopic procedures is not well understood. We sought to examine the impact of resident involvement on outcomes after bariatric surgery using a population-based clinical registry., Study Design: We analyzed 17,057 patients who underwent a primary laparoscopic gastric bypass in the 35-hospital Michigan Bariatric Surgery Collaborative from July 2006 to August 2012. Resident involvement was characterized at the surgeon level. Using hierarchical logistic regression, we examined the influence of resident involvement on 30-day complications, accounting for patient characteristics as well as hospital and surgeon case volume. To evaluate potential mediating factors for specific complications, we also adjusted for operative duration., Results: Risk-adjusted 30-day complication rates with and without residents were 13.0% and 8.5%, respectively (p < 0.01). Resident involvement was independently associated with wound infection (odds ratio [OR] = 2.06; 95% CI, 1.24-3.43) and venous thromboembolism (OR = 2.01; 95% CI, 1.19-3.40), but not with any other medical or surgical complications. Operative duration was longer with resident involvement (median duration with residents 129 minutes vs 88 minutes without; p < 0.01). After adjusting for operative duration, resident involvement was still independently associated with wound infection (OR = 1.67; 95% CI, 1.01-2.76), but not venous thromboembolism (OR = 1.73; 95% CI, 0.99-3.04)., Conclusions: Resident involvement in laparoscopic gastric bypass is independently associated with wound infections and venous thromboembolism. The effect appears to be mediated in part by longer operative times. These findings highlight the importance of strategies to assess and improve resident technical proficiency outside the operating room., (Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the comparative effectiveness of sleeve gastrectomy (SG), laparoscopic gastric bypass (RYGB), and laparoscopic adjustable gastric banding (LAGB) procedures., Background: Citing limitations of published studies, payers have been reluctant to provide routine coverage for SG for the treatment of morbid obesity., Methods: Using data from an externally audited, statewide clinical registry, we matched 2949 SG patients with equal numbers of RYGB and LAGB patients on 23 baseline characteristics. Outcomes assessed included complications occurring within 30 days, and weight loss, quality of life, and comorbidity remission at 1, 2, and 3 years after bariatric surgery., Results: Matching resulted in cohorts of SG, RYGB, and LAGB patients that were well balanced on baseline characteristics. Overall complication rates among patients undergoing SG (6.3%) were significantly lower than for RYGB (10.0%, P < 0.0001) but higher than for LAGB (2.4%, P < 0.0001). Serious complication rates were similar for SG (2.4%) and RYGB (2.5%, P = 0.736) but higher than for LAGB (1.0%, P < 0.0001). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB (69%, P < 0.0001), but was 77% higher for SG than for LAGB (34%, P < 0.0001). SG was similarly closer to RYGB than LAGB with regard to remission of obesity-related comorbidities., Conclusions: With better weight loss than LAGB and lower complication rates than RYGB, SG is a reasonable choice for the treatment of morbid obesity and should be covered by both public and private payers.

Background: The United States Food and Drug Administration recently issued a warning about adverse events in patients receiving inferior vena cava (IVC) filters., Objective: To assess relationships between IVC filter insertion and complications while controlling for differences in baseline patient characteristics and medical venous thromboembolism prophylaxis., Design: Propensity-matched cohort study., Setting: The prospective, statewide, clinical registry of the Michigan Bariatric Surgery Collaborative., Patients: Bariatric surgery patients (n=35,477) from 32 hospitals during the years 2006 through 2012., Intervention: Prophylactic IVC filter insertion., Measurements: Outcomes included the occurrence of complications (pulmonary embolism, deep vein thrombosis, and overall combined rates of complications by severity) within 30 days of bariatric surgery., Results: There were no significant differences in baseline characteristics among the 1,077 patients with IVC filters and in 1,077 matched control patients. Patients receiving IVC filters had higher rates of pulmonary embolism (0.84% vs 0.46%; odds ratio [OR], 2.0; 95% confidence interval [CI], 0.6-6.5; P=0.232), deep vein thrombosis (1.2% vs 0.37%; OR, 3.3; 95% CI, 1.1-10.1; P=0.039), venous thromboembolism (1.9% vs 0.74%; OR, 2.7; 95% CI, 1.1-6.3, P=0.027), serious complications (5.8% vs 3.8%; OR, 1.6; 95% CI, 1.0-2.4; P=0.031), permanently disabling complications (1.2% vs 0.37%; OR, 4.3; 95% CI, 1.2-15.6; P=0.028), and death (0.7% vs 0.09%; OR, 7.0; 95% CI, 0.9-57.3; P=0.068). Of the 7 deaths among patients with IVC filters, 4 were attributable to pulmonary embolism and 2 to IVC thrombosis/occlusion., Conclusions: We have identified no benefits and significant risks to the use of prophylactic IVC filters among bariatric surgery patients and believe that their use should be discouraged., (Copyright © 2013 Society of Hospital Medicine.)

Objective: To assess relationships between safety culture and complications within 30 days of bariatric surgery., Background: Safety culture refers to the quality of teamwork, coordination, and communication, as well as responses to error in health care settings. Although safety culture is thought to be an important determinant of surgical outcomes, few studies have examined this empirically., Methods: We surveyed staff from 22 Michigan hospitals participating in a statewide bariatric surgery collaborative. Each safety culture survey item was rated on a 1 to 5 Likert scale with lower scores representing better patient safety culture. These data were linked to clinical registry data for 24,117 bariatric surgery patients between 2007 and 2010. We used negative binomial regression to calculate incidence rates and incidence rate ratios measuring the increase in hospitals' rate of complications per unit increase in safety culture (individual items as well as hospital and operating room-specific subscales), controlling for patient risk factors, procedure mix, and bariatric procedure volume., Results: All 22 hospitals participated in this study, submitting safety culture ratings from 53 surgeons, 102 nurses, and 29 operating room administrators. Rates of serious complications were significantly lower among hospitals receiving an overall safety rating of excellent from nurses (1.5%), compared with those receiving a very good (2.6%) or acceptable (4.6%) rating (P = <0.0001). Surgeons' overall safety ratings were also associated with rates of serious complications (2.1% excellent, 2.6% very good, 4.7% acceptable, P = 0.011). Nurses' ratings of the hospital-specific subscale (P = 0.002) and surgeons' ratings of the operating room-specific subscale (P = 0.045) were also associated with rates of serious complications. Of the individual items, those related to coordination and communication between hospital units were the most strongly associated with rates of complications. Operating room administrator ratings of safety culture were not related to rates of complications for any of the domains of safety culture studied., Conclusions: Safety culture is associated with rates of serious surgical complications in bariatric surgery. Although nurses provide better information about hospital safety culture, surgeons are better judges of safety culture in the operating room. Interventions targeting safety culture, particularly coordination and communication, seem to be important for quality improvement.

Objective: We sought to identify risk factors for venous thromboembolism (VTE) among patients undergoing bariatric surgery in Michigan., Background: VTE remains a major source of morbidity and mortality after bariatric surgery. It is unclear which factors should be used to identify patients at high risk for VTE., Methods: The Michigan Bariatric Surgery Collaborative maintains a prospective clinical registry of bariatric surgery patients. For this study, we identified all patients undergoing primary bariatric surgery between June 2006 and April 2011 and determined rates of VTE. Potential risk factors for VTE were analyzed using a hierarchical logistic regression model, accounting for clustering of patients within hospitals. Significant risk factors were used to develop a risk calculator for development of VTE after bariatric surgery., Results: Among 27,818 patients who underwent bariatric surgery during the study period, 93 patients (0.33%) experienced a VTE complication, including 51 patents with pulmonary embolism. There were 8 associated deaths. Significant risk factors included previous history of VTE (OR 4.15, CI 2.42-7.08); male gender (OR 2.08, CI 1.36-3.19); operative time more than 3 hours (OR 1.86, CI 1.07-3.24); BMI category (per 10 units) (OR 1.37, CI 1.06-1.75); age category (per 10 years) (OR 1.25, CI 1.03-1.51); and procedure type (reference adjustable gastric band): duodenal switch (OR 9.45, CI 2.50-35.97); open gastric bypass (OR 6.48, CI 2.17-19.41); laparoscopic gastric bypass (OR 3.97, CI 1.77-8.91); and sleeve gastrectomy (OR 3.50, CI 1.30-9.34). Nearly 97% of patients had a predicted VTE risk less than 1%., Conclusions: In this population-based study, overall VTE rates were low among patients undergoing bariatric surgery. The use of an empirically based risk calculator will allow for the development of a risk-stratified approach to VTE prophylaxis.

Objectives: To develop a risk prediction model for serious complications after bariatric surgery., Background: Despite evidence for improved safety with bariatric surgery, serious complications remain a concern for patients, providers and payers. There is little population-level data on which risk factors can be used to identify patients at high risk for major morbidity., Methods: The Michigan Bariatric Surgery Collaborative is a statewide consortium of hospitals and surgeons, which maintains an externally-audited prospective clinical registry. We analyzed data from 25,469 patients undergoing bariatric surgery between June 2006 and December 2010. Significant risk factors on univariable analysis were entered into a multivariable logistic regression model to identify factors associated with serious complications (life threatening and/or associated with lasting disability) within 30 days of surgery. Bootstrap resampling was performed to obtain bias-corrected confidence intervals and c-statistic., Results: Overall, 644 patients (2.5%) experienced a serious complication. Significant risk factors (P < 0.05) included: prior VTE (odds ratio [OR] 1.90, confidence interval [CI] 1.41-2.54); mobility limitations (OR 1.61, CI 1.23-2.13); coronary artery disease (OR 1.53, CI 1.17-2.02); age over 50 (OR 1.38, CI 1.18-1.61); pulmonary disease (OR 1.37, CI 1.15-1.64); male gender (OR 1.26, CI 1.06-1.50); smoking history (OR 1.20, CI 1.02-1.40); and procedure type (reference lap band): duodenal switch (OR 9.68, CI 6.05-15.49); laparoscopic gastric bypass (OR 3.58, CI 2.79-4.64); open gastric bypass (OR 3.51, CI 2.38-5.22); sleeve gastrectomy (OR 2.46, CI 1.73-3.50). The c-statistic was 0.68 (bias-corrected to 0.66) and the model was well-calibrated across deciles of predicted risk., Conclusions: We have developed and validated a population-based risk scoring system for serious complications after bariatric surgery. We expect that this scoring system will improve the process of informed consent, facilitate the selection of procedures for high-risk patients, and allow for better risk stratification across studies of bariatric surgery.

There is evidence that collaborations between hospitals and physicians in particular regions of the country have led to improvements in the quality of care. Even so, there have not been many of these collaborations. We review one, the Michigan regional collaborative improvement program, which was paid for by a large private insurer, has yielded improvements for a range of clinical conditions, and has reduced costs in several important areas. In general and vascular surgery alone, complications from surgery dropped almost 2.6 percent among participating Michigan hospitals-a change that translates into 2,500 fewer Michigan patients with surgical complications each year. Estimated annual savings from this one collaborative are approximately $20 million, far exceeding the cost of administering the program. Regional collaborative improvement programs should become increasingly attractive to hospitals and physicians, as well as to national policy makers, as they seek to improve health care quality and reduce costs.

Context: Despite the growing popularity of bariatric surgery, there remain concerns about perioperative safety and variation in outcomes across hospitals., Objective: To assess complication rates of different bariatric procedures and variability in rates of serious complications across hospitals and according to procedure volume and center of excellence (COE) status., Design, Setting, and Patients: Involving 25 hospitals and 62 surgeons statewide, the Michigan Bariatric Surgery Collaborative (MBSC) administers an externally audited, prospective clinical registry. We evaluated short-term morbidity in 15,275 Michigan patients undergoing 1 of 3 common bariatric procedures between 2006 and 2009. We used multilevel regression models to assess variation in risk-adjusted complication rates across hospitals and the effects of procedure volume and COE designation (by the American College of Surgeons or American Society for Metabolic and Bariatric Surgery) status., Main Outcome Measure: Complications occurring within 30 days of surgery., Results: Overall, 7.3% of patients experienced perioperative complications, most of which were wound problems and other minor complications. Serious complications were most common after gastric bypass (3.6%; 95% confidence interval [CI], 3.2%-4.0%), followed by sleeve gastrectomy (2.2%; 95% CI, 1.2%-3.2%), and laparoscopic adjustable gastric band (0.9%; 95% CI, 0.6%-1.1%) procedures (P < .001). Mortality occurred in 0.04% (95% CI, 0.001%-0.13%) of laparoscopic adjustable gastric band, 0 sleeve gastrectomy, and 0.14% (95% CI, 0.08%-0.25%) of the gastric bypass patients. After adjustment for patient characteristics and procedure mix, rates of serious complications varied from 1.6% (95% CI, 1.3-2.0) to 3.5% (95% CI, 2.4-5.0) (risk difference, 1.9; 95% CI, 0.08-3.7) across hospitals. Average annual procedure volume was inversely associated with rates of serious complications at both the hospital level (< 150 cases, 4.1%; 95% CI, 3.0%-5.1%; 150-299 cases, 2.7%; 95% CI, 2.2-3.2; and > or = 300 cases, 2.3%; 95% CI, 2.0%-2.6%; P = .003) and surgeon level (< 100 cases, 3.8%; 95% CI, 3.2%-4.5%; 100-249 cases, 2.4%; 95% CI, 2.1%-2.8%; > or = 250 cases, 1.9%; 95% CI, 1.4%-2.3%; P = .001). Adjusted rates of serious complications were similar in COE and non-COE hospitals (COE, 2.7%; 95% CI, 2.5%-3.1%; non-COE, 2.0%; 95% CI, 1.5%-2.4%; P = .41)., Conclusions: The frequency of serious complications among patients undergoing bariatric surgery in Michigan was relatively low. Rates of serious complications are inversely associated with hospital and surgeon procedure volume, but unrelated to COE accreditation by professional organizations.

Objective: To determine if prior training on the LapMentor laparoscopic simulator leads to improved performance of basic laparoscopic skills in the animate operating room environment., Summary Background Data: Numerous influences have led to the development of computer-aided laparoscopic simulators: a need for greater efficiency in training, the unique and complex nature of laparoscopic surgery, and the increasing demand that surgeons demonstrate competence before proceeding to the operating room. The LapMentor simulator is expensive, however, and its use must be validated and justified prior to implementation into surgical training programs., Methods: Nineteen surgical interns were randomized to training on the LapMentor laparoscopic simulator (n = 10) or to a control group (no simulator training, n = 9). Subjects randomized to the LapMentor trained to expert criterion levels 2 consecutive times on 6 designated basic skills modules. All subjects then completed a series of laparoscopic exercises in a live porcine model, and performance was assessed independently by 2 blinded reviewers. Time, accuracy rates, and global assessments of performance were recorded with an interrater reliability between reviewers of 0.99., Results: LapMentor trained interns completed the 30 degrees camera navigation exercise in significantly less time than control interns (166 +/- 52 vs. 220 +/- 39 seconds, P < 0.05); they also achieved higher accuracy rates in identifying the required objects with the laparoscope (96% +/- 8% vs. 82% +/- 15%, P < 0.05). Similarly, on the two-handed object transfer exercise, task completion time for LapMentor trained versus control interns was 130 +/- 23 versus 184 +/- 43 seconds (P < 0.01) with an accuracy rate of 98% +/- 5% versus 80% +/- 13% (P < 0.001). Additionally, LapMentor trained interns outperformed control subjects with regard to camera navigation skills, efficiency of motion, optimal instrument handling, perceptual ability, and performance of safe electrocautery., Conclusions: This study demonstrates that prior training on the LapMentor laparoscopic simulator leads to improved resident performance of basic skills in the animate operating room environment. This work marks the first prospective, randomized evaluation of the LapMentor simulator, and provides evidence that LapMentor training may lead to improved operating room performance.