Comparison of 4-Year Health Care Expenditures Associated With Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy.

Importance: Data on the long-term health care expenditures associated with bariatric surgery consisting of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy are lacking. Objective: To compare 4-year health care expenditures after RYGB vs sleeve gastrectomy, identify factors independently associated with 4-year health care expenditures, and compare the procedures in terms of subsequent hospitalizations, bariatric procedures, and all-cause mortality. Design, Setting, and Participants: In this propensity score-matched cohort study, all residents of Ontario, Canada, who underwent publicly funded surgery with RYGB (n = 6301) or sleeve gastrectomy (n = 926) from March 1, 2010, to March 31, 2015, and consented to participate in the Ontario Bariatric Registry were eligible for the study. Follow-up was completed on March 31, 2019, and data were analyzed from May 5, 2020, to May 20, 2021. Interventions: RYGB and sleeve gastrectomy. Main Outcomes and Measures: Publicly funded health care expenditures, subsequent hospitalizations, bariatric procedures, and mortality during the 4 years after RYGB or sleeve gastrectomy. Results: The 1:1 matched study cohorts consisted of 1624 patients (812 per cohort) with a mean (SD) age of 48.0 (10.6) years, and 1242 women (76.5%). The mean body mass index (calculated as weight in kilograms divided by height in square meters) was 51.9 (8.3) for the RYGB cohort and 51.9 (8.9) for the sleeve gastrectomy cohort. The 4-year cumulative costs were not statistically significantly different between RYGB and sleeve gastrectomy (mean [SD], $33 682 [$31 169] vs $33 948 [$32 633], respectively; P = .86). Having a history of coronary artery disease was associated with a 35% increase in overall health care expenditures; chronic kidney disease, a 54% increase; and mental health admissions, a 67% increase. There were no statistically significant differences in all-cause mortality between RYGB and sleeve gastrectomy (1.5% vs 2.2%, respectively; P = .26) or the total number of hospitalizations (754 vs 669, respectively; P = .11) during the 4-year follow-up period. However, nonelective hospitalizations occurred more frequently with RYGB vs sleeve gastrectomy (472 vs 339, respectively; P = .002). Roux-en-Y gastric bypass was associated with relatively fewer subsequent bariatric procedures during the 4-year follow-up period (9 vs 40, respectively; P < .001). Conclusions and Relevance: In this Canadian population-based study, key results indicated that 4-year health care expenditures, all-cause mortality, and number of hospital admissions associated with RYGB did not significantly differ from those for sleeve gastrectomy. The rate of subsequent bariatric surgery was lower with RYGB. This study identified important patient-level drivers of health care expenditures that need to be further investigated.

Association of Roux-en-Y Gastric Bypass With Postoperative Health Care Use and Expenditures in Canada.

Importance: Results of previous studies are mixed regarding the economic implications of a Roux-en-Y gastric bypass (RYGB). Objective: To assess the 5-year incremental health care use and expenditures after RYGB. Design, Setting, and Participants: This population-based cohort study conducted in Ontario, Canada, used a difference-in-differences approach to compare health care use and expenditures between patients who underwent a publicly funded RYGB from March 1, 2010, to March 31, 2013, and propensity score-matched control individuals who did not undergo a surgical bariatric procedure. The study period allowed for a minimum 60 months of follow-up because, at that time, the most recent date for which administrative data on health care and expenditures were available was March 31, 2018. Data sources included the Ontario Bariatric Registry linked to several Ontario health administrative databases and the Electronic Medical Record Administrative Data Linked Database. Health care use and expenditures data for 5 years before and 5 years after the index date (procedure date for RYGB group; random date for controls) were analyzed. Data analyses were performed March 12, 2019, to March 10, 2020. Intervention: RYGB procedure. Main Outcomes and Measures: The primary outcome was total health care expenditures. Results: The final propensity score-matched cohorts comprised 1587 individuals in the RYGB group (mean [SD] age, 47 [10.2] years) and 1587 controls (mean [SD] age, 47 [12.2] years); each group had 1228 women (77.4%) and a mean body mass index (calculated as weight in kilograms divided by height in meters squared) of 46. Mean total health care expenditures (2017 Canadian dollars) per patient in the RYGB group increased from CAD $15 594 (95% CI, CAD $14 743 to CAD $16 614) (US $12 008 [95% CI, US $11 353 to US $12 794]) in the 5 years before the procedure to CAD $30 389 (95% CI, CAD $28 789 to CAD $32 232) (US $23 401 [95% CI, US $22 169 to US $24 821]) over the 5 years after the procedure, a difference of CAD $14 795 (95% CI, CAD $13 172 to CAD $16 480) (US $11 393 [95% CI, US $10 143 to US $12 691]). For the control group, mean total health care expenditures per individual increased from CAD $16 109 (95% CI, CAD $14 727 to CAD $17 591) (US $12 405 [95% CI, US $11 341 to US $13 546]) 5 years before the index date to CAD $20 073 (95% CI, CAD $18 147 to CAD $22 169) (US $15 457 [95% CI, US $13 974 to US $17 071]) 5 years after the date, a difference of CAD $3964 (95% CI, CAD $2250 to CAD $5875) (US $3053 [95% CI, US $1733 to US $4524]). Overall, the difference-in-differences estimate of the net cost of RYGB was CAD $10 831 (95% CI, CAD $8252 to CAD $13 283) (US $8341 [95% CI, $6355 to $10 229]) over the 5-year period. This amount excluded the mean (SD) cost associated with the index date: CAD $6501 (CAD $1087) (US $5006 [US $837]) for the RYGB cohort and CAD $9 (CAD $72) (US $7 [US $55]) for the controls. The cost differential was primarily associated with increased hospitalizations in the first months immediately after RYGB. Expenditures leveled off in year 3 after the index date; differences in total expenditures between the RYGB and control cohorts were not statistically significantly different in years 4 and 5. Conclusions and Relevance: Health care expenditures in the 3 years after publicly funded RYGB were higher in patients who underwent the procedure than in control individuals, but the costs were similar thereafter. This finding suggests the need to decrease hospital and emergency department readmissions after surgical bariatric procedures because such use is associated with increased spending.

The hidden cost of an extensive preoperative work-up: predictors of attrition after referral for bariatric surgery in a universal healthcare system.

BACKGROUND: Bariatric surgery is in high demand and patients generally undergo an extensive work-up process to maximize the success of surgery, especially in universal healthcare systems. Although valuable, this work-up process can lead to attrition before surgery. Therefore, we aim to assess patient and health system factors associated with attrition after bariatric surgery referral in a universal healthcare system. METHODS: This was a population-based study of all patients aged ≥ 18 referred for bariatric surgery in Ontario, Canada from 2009 to 2015. Primary outcome was patients who dropped out of bariatric surgery after referral. Predictors of attrition after referral included patient demographics, clinical, institutional, and socioeconomic variables. Odds ratios and 95% CIs were estimated by multilevel logistic regression models. RESULTS: From 17,703 patients that were referred for bariatric surgery, 4122 patients dropped after the initial referral. Male patients, increasing age, and longer wait times for surgery were significantly (P < 0.0001) associated with higher odds of attrition. Additionally, smoker status, immigration status, unemployment, and disability were significant factors (P < 0.0001) predicting attrition. Patients who lived in lowest income quintile neighborhoods, when compared to those from the richest neighborhoods, had significantly higher odds of attrition (P = 0.02). Sleep apnea was associated with lower odds of attrition while diabetes and heart failure both with higher odds of attrition. CONCLUSION: Even in a universal healthcare system, there are various factors that could lead to increased odds of attrition before bariatric surgery. Clear disparities exist for certain marginalized populations. Further studies are warranted to ensure equitable utilization of bariatric surgery for all patients.

A Longitudinal Analysis of Wait Times for Bariatric Surgery in a Publicly Funded, Regionalized Bariatric Care System.

BACKGROUND: Bariatric surgery is proven to be the most effective strategy for management of obesity and its related comorbidities. However, in Canada, patients awaiting bariatric surgery can be subjected to prolonged wait times, thereby subjecting them to increased morbidity and mortality, as well as decreased psychosocial well-being. OBJECTIVE: To assess the factors associated with prolonged wait times for bariatric surgery within a publicly funded, provincial bariatric network. METHODS: This was a retrospective population-based study of all patients aged > 18 years who were referred for bariatric surgery from April 2009 to May 2015 using linked administrative databases to capture patient demographic data, socioeconomic variables, healthcare utilization, and institutional factors. The main outcome of interest was a wait time greater than 18 months. Multivariate logistic regression modeling was used to estimate odds ratios (OR) and 95% confidence intervals (CI). RESULTS: A total of 18,854 patients underwent bariatric surgery from April 2009 to December 2016, of which 2407 patients experienced wait times of > 18 months. On average, yearly wait times have increased for patients receiving surgery with wait times of 10.98 months (SD 5.48) in 2010 and 13.09 (SD 6.69) in 2016 (p < 0.001). Increasing age (OR 1.12, 95% CI 1.05-1.19, p = 0.0004), BMI (OR 1.08, 95% CI 1.04-1.11, p < 0.001), and male gender (OR 1.47, 95% CI 1.28-1.70, p < 0.001) were significantly associated with increased bariatric surgery wait times. Additionally, smoking status (OR 1.46, 95% CI 1.09-1.97, p = 0.0118) and obesity-related comorbidities particularly diabetes (OR 1.29, 95% CI 1.14-1.44, p < 0.001) and heart failure (OR 1.72, 95% CI 1.43-2.07, p < 0.001) were correlated with prolonged wait times for surgery. Socioeconomic variables including disability (OR 1.64, 95% CI 1.38-1.92, p < 0.001) and immigration status (OR 1.35, 95% 1.11-1.64, p = 0.003) were correlated with increased odds of longer wait times, as were regions with regionalized assessment and treatment centres (RATC) when referenced against centers of excellence (COEs) in number of days added with 20.45 (95% CI 13.20-27.70, p < 0.001). CONCLUSION: Wait times for bariatric surgery in a publicly funded, regionalized bariatric program are influenced by certain patient characteristics, socioeconomic variables, and institutional factors. This warrants further intervention and study to help improve these inequities when encountering potentially vulnerable populations awaiting bariatric surgery.

The value of surgical experience: excess costs associated with the Roux-en-Y gastric bypass learning curve.

BACKGROUND: Gastric bypass has a steep learning curve that is associated with increased adverse outcomes and these adverse outcomes are associated with increases in cost. This study sought to quantify the effect of cumulative procedure volume on inpatient cost and characterize the excess cost associated with a surgeon's learning curve. METHODS: This was a retrospective study of 29 high-volume surgeons during the first 6 years of performing gastric bypass in a regionalized center of excellence system. Cumulative volume was determined using the procedure date and analyzed in blocks of 25 cases. The main outcomes of interest were inpatient cost for the initial hospital stay in 2014 Canadian dollars as well as prolonged length of stay (≥ 3 days). RESULTS: Overall, 11,684 cases were identified from April 2009 to March 2015. After a surgeon's 50th case, the adjusted inpatient cost decreased by $2775 (95% CI $- 4352 to $- 1204 p = 0.001) compared to the first 25 cases. Cost savings were maintained through a surgeon's 400th case. The average cost savings after the 50th case was $2082 (95% CI $- 3194 to $- 962 p < 0.001) and the excess cost attributable to the first 50 cases was $104,077 (95% CI 48,104 to 159,682) per surgeon. Surgeon experience was also associated with a decrease odds of prolonged length of stay. CONCLUSIONS: This study demonstrated the influence of surgeon experience on improved cost efficiencies. We also characterized that the average excess cost per surgeon of implementing gastric bypass was approximately $104,000. This is relevant to future health system planning as well as providing an economic incentive for impactful training interventions.

Geographic variation in the provider of screening colonoscopy in Canada: a population-based cohort study.

BACKGROUND: Screening colonoscopy for the detection of colorectal carcinoma is provided by several specialties. Few studies have assessed geographic variation in the delivery of this care. Our objective was to investigate how geographic and socioeconomic factors affect who provides screening colonoscopy in Canada. METHODS: This was a population-based cohort of all screening colonoscopy procedures performed at publicly funded Canadian health care facilities (excluding those in Quebec) between April 2008 and March 2015. The main outcome of interest was the proportion of colonoscopy procedures performed by surgeons versus gastroenterologists at the neighbourhood level. Predictors of interest included socioeconomic and geographic variables. We used spatial analysis to evaluate significant clustering of practitioner services and multinomial logistic regression to model predictors. RESULTS: We identified 658 113 screening colonoscopy procedures performed by 1886 providers (1169 surgeons and 717 gastroenterologists) over the study period, of which 353 165 (53.7%) were performed by surgeons. A total of 24.2% of neighbourhoods were located within clusters predominantly served by gastroenterologists, and 19.5% were within surgeon clusters; the remainder were in mixed clusters. Rural neighbourhoods had a significantly increased relative risk of being within a surgeon cluster (relative risk [RR] 5.38, 95% confidence interval [CI] 3.48-8.01) compared to mixed clusters and nearly 100 times higher relative risk of being in a surgeon cluster compared to gastroenterologist clusters (RR 98.95, 95% CI 15.3-427.2). Neighbourhoods with the highest socioeconomic status were 1.74 (95% CI 1.14-2.56) times likelier to be in gastroenterologist clusters than in mixed clusters. INTERPRETATION: Surgeons provide a large proportion of colonoscopy procedures in Canada and are essential for access to care, particularly in rural regions. Most Canadians are served relatively equally by surgeons and gastroenterologists. This emphasizes the importance of both specialties to the delivery of colonoscopy care across the country.

A Longitudinal Analysis of Short-Term Costs and Outcomes in a Regionalized Center of Excellence Bariatric Care System.

BACKGROUND: Evaluating how morbidity and costs evolve for new bariatric centers is vital to understanding the expected length of time required to reach optimal outcomes and cost efficiencies. Accordingly, the objective of this study was to evaluate how morbidity and costs changed longitudinally during the first 5 years of a regionalized center of excellence system. METHODS: This was a longitudinal analysis of the first 5 years of a bariatric center of excellence system. The main outcomes of interest were all-cause morbidity and cost for the index admission. Predictors of interest included patient demographics, comorbidities, annual hospital and surgeon volume, fellowship teaching center status, and year of procedure. Hierarchical regression models were used to determine predictors of morbidity and costs. RESULTS: Procedures done in 2012 (OR 0.65, 95%CI 0.52-0.79; p < 0.001), 2013 (OR 0.63, 95%CI 0.51-0.78; p < 0.001), and 2014 (OR 0.53, 95%CI 0.43-0.65; p < 0.001) all conferred a significantly lower odds of morbidity when compared to the initial 2009/2010 years. Surgeon volume was associated with a decreased odds of morbidity as for each increase in 25 bariatric cases per year the odds of all-cause morbidity was 0.94 lower (95%CI 0.88-1.00; p = 0.04). There was no significant variation at the hospital or surgeon level in perioperative outcomes. CONCLUSION: This study determined that volume was important even for high resource, fellowship-trained surgeons. It also found a decrease in morbidity over time for new centers. Lastly, there was little variation in outcomes across hospitals and surgeons suggesting that strict accreditation standards can help to ensure high quality across hospital sites.

The effect of health system factors on outcomes and costs after bariatric surgery in a universal healthcare system: a national cohort study of bariatric surgery in Canada.

INTRODUCTION: Previous data demonstrate that patients who receive bariatric surgery at a Center of Excellence are different than those who receive care at non-accredited centers. Canada provides a unique opportunity to naturally exclude confounders such as insurance status, hospital ownership, and lack of access on comparisons between hospitals and surgeons in bariatric surgery outcomes. The objective of this study was to determine the effect of hospital accreditation and other health system factors on all-cause morbidity after bariatric surgery in Canada. METHODS: This was a population-based study of all patients aged ≥18 who received a bariatric procedure in Canada (excluding Quebec) from April 2008 until March 2015. The main outcomes for this study were all-cause morbidity and costs during the index admission. All-cause morbidity included any documented complication which extended length of stay by 24 h or required reoperation. Risk-adjusted hierarchical regression models were used to determine predictors of morbidity and cost. RESULTS: Overall, 18,398 patients were identified and the all-cause morbidity rate was 10.1%. Surgeon volume and teaching hospitals were both found to significantly decrease the odds of all-cause morbidity. Specifically, for each increase in 25 bariatric cases per year, the odds of all-cause morbidity was 0.94 times lower (95% CI 0.87-1.00, p = 0.03). Teaching hospitals conferred a 0.75 lower odds of all-cause morbidity (95% CI 0.58-0.95, p < 0.001). Importantly, formal accreditation was not associated with a decrease in all-cause morbidity within a universal healthcare system. No health system factors were associated with significant cost differences. CONCLUSION: This national cohort study found that surgeon volume and teaching hospitals predicted lower all-cause morbidity after surgery while hospital accreditation was not a significant factor.

The Effect of Bariatric Surgery on Mobility, Health-Related Quality of Life, Healthcare Resource Utilization, and Employment Status.

BACKGROUND: A sub-study of the Ontario Bariatric Registry was conducted to evaluate the impact of bariatric surgery on mobility, health-related quality of life (HRQoL), healthcare resource utilization (HRU), and employment status. METHODS: The 1-year change in mobility following bariatric surgery was evaluated using the mobility domain of the EuroQOL-5D-5L (EQ-5D-5L), which was self-administered at baseline and 1 year after bariatric surgery along with questions on HRU. Another questionnaire was used to document employment status at time of surgery and 1 year later. RESULTS: The population included 304 individuals (mean age = 46 years; 85 % female). At baseline, 68 % of participants had some problems in walking compared to 14 % at 1 year following surgery (p < 0.001). The EQ-5D-5L health utility score increased from 0.73 to 0.90 (p < 0.001). The number of hospitalizations increased significantly before and after surgery (p = 0.021). Of the 304 study participants, 138 completed the questionnaire and responses indicated that more individuals reported a change in their employment status within 1 year following surgery (26 %) compared to 1 year prior to the surgery (9 %) (p < 0.001). CONCLUSIONS: Within the limitations of this study, there is a suggestion that bariatric surgery has a major impact on mobility and HRQoL. More research is warranted to understand the benefits, costs, and cost-effectiveness of bariatric surgery in Canada.

Regional Variations in the Public Delivery of Bariatric Surgery: An Evaluation of the Center of Excellence Model.

OBJECTIVE: We evaluated regional access to bariatric surgery within the high-volume, center of excellence (COE) model of Ontario, Canada. BACKGROUND: In 2009, Ontario implemented Canada's first regionalized bariatric surgical care system based on a COE. Because of this, a small number of COEs service a large population and geographic area. METHODS: This study identified all patients older than 18 years, who received bariatric surgery from April 2009 to March 2012. Morbid obesity-adjusted rates of surgery were then calculated for each neighborhood, and a cluster analysis was performed to determine aggregation of neighborhoods with significantly higher (hot spots) or lower (cold spots) rates of surgery. Ordinal logistic regression was used to identify independent predictors of neighborhood access. RESULTS: The cluster analysis identified 49 cold spot neighborhoods, representing 1.7 million people. Forty of these neighborhoods lie within a relatively small area that contains 3 of the 4 COEs. In the multivariate analysis, for every 100 km from the nearest COE, neighborhoods were 0.88 times as likely to live in a hot spot [95% CI (confidence interval): 0.80-0.97; P = 0.012]. In addition, having a bariatric facility within the same administrative health region as the neighborhood made it almost twice as likely to be a hot spot, odds ratio = 1.75 (95% CI: 1.10-2.79; P = 0.018). Low neighborhood socioeconomic status was not associated with decreased delivery of care. CONCLUSIONS: This study identified an unequal delivery of bariatric surgery within Ontario. Both longer distances and not having a bariatric facility within the same health region had significant negative effects. Further research into patient attitudes and referral patterns is required to better characterize these disparities.

Cost-utility of laparoscopic Nissen fundoplication versus proton pump inhibitors for chronic and controlled gastroesophageal reflux disease: a 3-year prospective randomized controlled trial and economic evaluation.

BACKGROUND: Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results. OBJECTIVES: To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective. METHODS: Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis. RESULTS: No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis. CONCLUSIONS: Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.

Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy.

BACKGROUND: Simulators may improve the efficiency, safety, and quality of endoscopic training. However, no objective, reliable, and valid tool exists to assess clinical endoscopic skills. Such a tool to measure the outcomes of educational strategies is a necessity. This multicenter, multidisciplinary trial aimed to develop instruments for evaluating basic flexible endoscopic skills and to demonstrate their reliability and validity. METHODS: The Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) Upper Endoscopy (GAGES-UE) and Colonoscopy (GAGES-C) are rating scales developed by expert endoscopists. The GAGES scale was completed by the attending endoscopist (A) and an observer (O) in self-assessment (S) during procedures to establish interrater reliability (IRR, using the intraclass correlation coefficient [ICC]) and internal consistency (IC, using Cronbach's alpha). Instrumentation was evaluated when possible and correlated with total scores. Construct and external validity were examined by comparing novice (NOV) and experienced (EXP) endoscopists (Student's t-test). Correlations were calculated for GAGES-UE and GAGES-C with participants who had performed both. RESULTS: For the 139 completed evaluations (60 NOV, 79 EXP), IRR (A vs. O) was 0.96 for GAGES-UE and 0.97 for GAGES-C. The IRR between S and A was 0.78 for GAGES-UE and 0.89 for GAGES-C. The IC was 0.89 for GAGES-UE, and 0.95 for GAGES-C. There were mean differences between the NOV and the EXP endoscopists for GAGE-UE (14.4 +/- 3.7 vs. 18.5 +/- 1.6; p < 0.001) and GAGE-C (11.8 +/- 3.8 vs. 18.8 +/- 1.3; p < 0.001). Good correlation was found between the scores for the GAGE-UE and the GAGE-C (r = 0.75; n = 37). Instrumentation, when performed, demonstrated correlations with total scores of 0.84 (GAGE-UE; n = 73) and 0.86 (GAGE-C; n = 45). CONCLUSIONS: The GAGES-UE and GAGES-C are easy to administer and consistent and meet high standards of reliability and validity. They can be used to measure the effectiveness of simulator training and to provide specific feedback. The GAGES results can be generalized to North American and European endoscopists and may contribute to the definition of technical proficiency in endoscopy.

Impact of information technology on human resources in healthcare.

Incorporation of advances in information communications technology (ICT) into the workplace has had a major impact in human resource utilization in sectors of the economy where it has occurred in a substantial manner, such as manufacturing and financial services. While some benefits of ICT have been realized in healthcare, the full impact of its benefits will only be realized if it is incorporated in a systematic form, rather than in the current patchy and uneven manner seen around the province and across the country to date.

Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial.

PURPOSE: Oncologic concerns from high wound recurrence rates prompted a multi-institutional randomized trial to test the hypothesis that disease-free and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy. METHODS: Eight hundred seventy-two patients with curable colon cancer were randomly assigned to undergo laparoscopic-assisted or open colectomy at 1 of 48 institutions by 1 of 66 credentialed surgeons. Patients were followed for 8 years, with 5-year data on 90% of patients. The primary end point was time to recurrence, tested using a noninferiority trial design. Secondary endpoints included overall survival and disease-free survival. (Kaplan-Meier) RESULTS: As of March 1, 2007, 170 patients have recurred and 252 have died. Patients have been followed a median of 7 years (range 5-10 years). Disease-free 5-year survival (Open 68.4%, Laparoscopic 69.2%, P=0.94) and overall 5-year survival (Open 74.6%, Laparoscopic 76.4%, P=0.93) are similar for the 2 groups. Overall recurrence rates were similar for the 2 groups (Open 21.8%, Laparoscopic 19.4%, P=0.25). These recurrences were distributed similarly between the 2 treatment groups. Sites of first recurrence were distributed similarly between the treatment arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%; Laparoscopic: wound 0.9%, liver 5.5%, lung 4.6%, other 6.1%). CONCLUSION: Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.