Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.
ABSTRACT: BACKGROUND:Bariatric surgery has been used for treatment of severe obesity in adolescents but most studies have been small and limited in follow-up. OBJECTIVES:We hypothesized that electronic health record data could be used to compare effectiveness of bariatric procedures in adolescents. SETTING:Data were obtained from clinical research networks using a common data model to extract data from each site. METHODS:Adolescents who underwent a primary bariatric procedure from 2005 through 2015 were identified. The percent change in body mass index (BMI) at 1, 3, and 5 years was estimated using random effects linear regression for patients undergoing all operations. Propensity score adjusted estimates and 95% confidence intervals were estimated for procedures with >25 patients at each time period. RESULTS:This cohort of 544 adolescents was predominantly female (79%) and White (66%), with mean (±standard deviation) age of 17.3 (±1.6) years and mean BMI of 49.8 (± 7.8) kg/m2. Procedures included Roux-en-Y gastric bypass (RYGB; n?=?177), sleeve gastrectomy (SG; n?=?306), and laparoscopic adjustable gastric banding (n?=?61). For those undergoing RYGB, SG, and laparoscopic adjustable gastric banding, mean (95% confidence interval) BMI changes of -31% (-30% to -33%), -28% (-27% to -29%), and -10% (-8% to -12%), were estimated at 1 year. For RYGB and SG, BMI changes of -29% (-26% to -33%) and -25% (-22% to -28%) were estimated at 3 years. CONCLUSIONS:Adolescents undergoing SG and RYGB experienced greater declines in BMI at 1- and 3-year follow-up time points, while laparoscopic adjustable gastric banding was significantly less effective for BMI reduction.
Project description:Bariatric surgery has proved to be an effective strategy in treating obesity. However, randomized controlled trials (RCTs) of 3 most common bariatric surgery procedures, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and laparoscopic adjustable gastric band (LAGB), reported inconsistent results. We performed a systematic review and network meta-analysis to synthesize evidence of effectiveness of the 3 common bariatric procedures from relevant RCTs.The present study was a systematic review and network meta-analysis of RCTs. All RCTs must meet the following criteria to be included in the analysis: patients with body mass index (BMI) ?30?kg/m, reported at least 1 outcome of interest, compared at least 2 of the 3 bariatric procedures, and had follow-ups of at least 1 year. Primary outcome was weight loss, expressed as differences in mean BMI reduction and percentage excess weight loss (%EWL) following 1 year after the surgery. Network meta-analysis was based on Bayesian framework with Markov Chain Monte Carlo simulation approach.Eleven RCTs that met the criteria were included in the review. Of 9 trials (n?=?765), the differences in mean BMI reduction were -0.76 (95% CI: -3.1 to 1.6) for RYGB versus SG, -5.8 (95% CI: -9.2 to -2.4) for RYGB versus LAGB, and -5.0 (95% CI: -9.0 to -1.0) for SG versus LAGB. Eight RCTs (n?=?656) reported percentage excess weight-loss (%EWL), the mean differences between RYGB and SG, RYGB and LAGB, and SG and LAGB were 3.8% (95% CI: -8.5% to 13.8%), -22.2% (95% CI: -34.7% to -6.5%), and -26.0% (95% CI: -40.6% to -6.4%), respectively. The meta-analysis indicated low heterogeneity between studies, and the node splitting analysis showed that the studies were consistent between direct and indirect comparisons (P?>?.05).The RYGB and SG yielded similar in weight-loss effect and both were superior to LAGB. Other factors such as complications and patient preference should be considered during surgical consultations.
Project description:Background:There has been a dramatic shift in use of bariatric procedures, but little is known about their long-term comparative effectiveness. Objective:To compare weight loss and safety among bariatric procedures. Design:Retrospective observational cohort study, January 2005 to September 2015. (ClinicalTrials.gov: NCT02741674). Setting:41 health systems in the National Patient-Centered Clinical Research Network. Participants:65 093 patients aged 20 to 79 years with body mass index (BMI) of 35 kg/m2 or greater who had bariatric procedures. Intervention:32 208 Roux-en-Y gastric bypass (RYGB), 29 693 sleeve gastrectomy (SG), and 3192 adjustable gastric banding (AGB) procedures. Measurements:Estimated percent total weight loss (TWL) at 1, 3, and 5 years; 30-day rates of major adverse events. Results:Total numbers of eligible patients with weight measures at 1, 3, and 5 years were 44 978 (84%), 20 783 (68%), and 7159 (69%), respectively. Thirty-day rates of major adverse events were 5.0% for RYGB, 2.6% for SG, and 2.9% for AGB. One-year mean TWLs were 31.2% (95% CI, 31.1% to 31.3%) for RYGB, 25.2% (CI, 25.1% to 25.4%) for SG, and 13.7% (CI, 13.3% to 14.0%) for AGB. At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points more than AGB patients, and SG patients lost 12.0 (CI, 11.6 to 12.5) percentage points more than AGB patients. Five-year mean TWLs were 25.5% (CI, 25.1% to 25.9%) for RYGB, 18.8% (CI, 18.0% to 19.6%) for SG, and 11.7% (CI, 10.2% to 13.1%) for AGB. Patients with diabetes, those with BMI less than 50 kg/m2, those aged 65 years or older, African American patients, and Hispanic patients lost less weight than patients without those characteristics. Limitation:Potential unobserved confounding due to nonrandomized design; electronic health record databases had missing outcome data. Conclusion:Adults lost more weight with RYGB than with SG or AGB at 1, 3, and 5 years; however, RYGB had the highest 30-day rate of major adverse events. Small subgroup differences in weight loss outcomes were observed. Primary Funding Source:Patient-Centered Outcomes Research Institute.
Project description:BACKGROUND:Apolipoprotein A-IV (ApoA-IV) has been shown to be involved in obesity and diabetes pathogenesis in animal studies, but its role in humans is uncertain. OBJECTIVES:The objective of this study was to determine the relation of ApoA-IV with changes in glucose metabolism and weight after bariatric surgery. SETTING:University Hospital. METHODS:The patients (n = 49) included lean controls (n = 8) and patients before and after a mean of 7 months after laparoscopic adjustable gastric banding (LAGB, n = 12), laparoscopic Roux-en-Y gastric bypass (RYGB, n = 22), or laparoscopic sleeve gastrectomy (SG, n = 11). ApoA-IV and other hormone assays were performed in the fasting and the postprandial state. Pearson's correlation analyses controlled for baseline BMI and percent excess weight loss (EWL) were used to determine relationships between ApoA-IV levels and insulin resistance (HOMA-IR). RESULTS:With all bariatric procedures combined, the change in ApoA-IV [533 versus 518 microg/L, P = .813] or ApoA-IV area under the curve (AUC - 1072 versus 1042, P = .939) was not significant. None of the surgeries individually affected levels of fasting or ApoA-IV AUC. Bariatric surgery resulted in a decrease in HOMA-IR (5.3 versus 2.0, P<.001). In the RYGB group, higher baseline ApoA-IV levels correlated with decrease in HOMA-IR [r = -.6, P = .008]. This relationship was independent of EWL and was not observed in the LAGB or SG group. There was no association of ApoA-IV levels with EWL, insulin secretion, Peptide-YY, or leptin levels. CONCLUSION:Preoperative ApoA-IV levels, rather than changes in levels, positively correlate with improvements in insulin sensitivity independent of weight loss after RYGB.
Project description:BACKGROUND:Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting. METHODS:Patients aged 14-16?years with sex- and age-adjusted BMI >?40?kg/m2 (or?>?35?kg/m2 with comorbidity) and failure to achieve weight reduction >?5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6?months, 1,2 and 3?years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. DISCUSSION:This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy. TRIAL REGISTRATION:The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.
Project description:BACKGROUND:The effectiveness of bariatric surgery among Medicaid beneficiaries, a population with a disproportionately high burden of obesity, remains unclear. We sought to determine if weight loss and regain following bariatric surgery differed in Medicaid patients compared to commercial insurance. SUBJECTS/METHODS:Data from the Longitudinal Assessment of Bariatric Surgery, a ten-site observational cohort of adults undergoing bariatric surgery (2006-2009) were examined for patients who underwent Roux-en-Y Gastric Bypass (RYGB), Laparoscopic Adjustable Band (LAGB), or Sleeve Gastrectomy (SG). Using piecewise spline linear mixed-effect models, weight change over 5 years was modeled as a function of insurance type (Medicaid, N?=?190; commercially insured, N?=?1448), time, procedure type, and sociodemographic characteristics; additionally, interactions between all time, insurance, and procedure type indicators allowed time- and procedure-specific associations with insurance type. For each time-spline, mean (kg) difference in weight change in commercially insured versus Medicaid patients was calculated. RESULTS:Medicaid patients had higher mean weight at baseline (138.3?kg vs. 131.2?kg). From 0 to 1 year post-operatively, Medicaid patients lost similar amounts of weight to commercial patients following all procedure types (mean weight ? difference [95% CI]: RYGB: -0.9 [-3.2, 1.4]; LAGB: -1.5 [-6.7, 3.8]; SG: 5.1 [-4.0, 14.2]). From 1 to 3 years post-operatively Medicaid and commercial patients continued to experience minimal weight loss or began to slowly regain weight (mean weight ? difference [95% CI]: RYGB: 0.9 [0.0, 2.0]; LAGB: -2.1 [-4.2, 0.1]; SG: 0.7 [-3.0, 4.3]). From 3 to 5 years post-operatively, the rate of regain tended to be faster among commercial patients compared to Medicaid patients (mean weight ? difference [95% CI]: RYGB: 1.1 [0.1, 2.0]; LAGB: 1.5 [-0.5, 3.5]; SG: 1.0 [-2.5, 4.5]). CONCLUSIONS:Although Medicaid patients had a higher baseline weight, they achieved similar amounts of weight loss and tended to regain weight at a slower rate than commercial patients.
Project description:Data on gastrointestinal (GI) side effects of bariatric surgery are limited because of incomplete reporting, cross-sectional samples, and nonstandardized assessments.To report on GI side effects over the first 6 months after Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB).Academic medical center, United States.One hundred forty-four patients completed a standardized clinical interview 6 months after operation, including questions on the occurrence and frequency of episodes of dumping syndrome, vomiting, and plugging for each of the past 6 months; monthly rates were stable, so results were averaged over the entire period. Although data were collected as part of a randomized controlled trial, randomization group and the interaction of group by surgical procedure were not related to GI side effects. Thus, results are reported by procedure only (RYGB, n = 87; LAGB, n = 56).RYGB patients had a higher preoperative body mass index (BMI) than LAGB patients (46.8±6.8 versus 43.5±4.8 kg/m(2), respectively; P = .001), were more likely to report dumping (45.7% versus 4.7%, P<.0001), and were less likely to report plugging (45.7% versus 79.1%, P = .0005). Vomiting did not differ significantly by procedure (68.6% versus 65.1%, P = .7). Most patients experienced each GI side effect less than once per week.Although self-reported GI side effects were common over the first 6 months after operation, the frequency of episodes was relatively low. Longer-term follow-up is needed to determine whether symptoms worsen or improve over time.
Project description:Bariatric surgery induces significant weight loss for severely obese patients, but there is limited evidence of the durability of weight loss compared with nonsurgical matches and across bariatric procedures.To examine 10-year weight change in a large, multisite, clinical cohort of veterans who underwent Roux-en-Y gastric bypass (RYGB) compared with nonsurgical matches and the 4-year weight change in veterans who underwent RYGB, adjustable gastric banding (AGB), or sleeve gastrectomy (SG).In this cohort study, differences in weight change up to 10 years after surgery were estimated in retrospective cohorts of 1787 veterans who underwent RYGB from January 1, 2000, through September 30, 2011 (573 of 700 eligible [81.9%] with 10-year follow-up), and 5305 nonsurgical matches (1274 of 1889 eligible [67.4%] with 10-year follow-up) in mixed-effects models. Differences in weight change up to 4 years were compared among veterans undergoing RYGB (n?=?1785), SG (n?=?379), and AGB (n?=?246). Data analysis was performed from September 9, 2014, to February 12, 2016.Bariatric surgical procedures and usual care.Weight change up to 10 years after surgery through December 31, 2014.The 1787 patients undergoing RYGB had a mean (SD) age of 52.1 (8.5) years and 5305 nonsurgical matches had a mean (SD) age of 52.2 (8.4) years. Patients undergoing RYGB and nonsurgical matches had a mean body mass index of 47.7 and 47.1, respectively, and were predominantly male (1306 [73.1%] and 3911 [73.7%], respectively). Patients undergoing RYGB lost 21% (95% CI, 11%-31%) more of their baseline weight at 10 years than nonsurgical matches. A total of 405 of 564 patients undergoing RYGB (71.8%) had more than 20% estimated weight loss, and 224 of 564 (39.7%) had more than 30% estimated weight loss at 10 years compared with 134 of 1247 (10.8%) and 48 of 1247 (3.9%), respectively, of nonsurgical matches. Only 19 of 564 patients undergoing RYGB (3.4%) regained weight back to within an estimated 5% of their baseline weight by 10 years. At 4 years, patients undergoing RYGB lost 27.5% (95% CI, 23.8%-31.2%) of their baseline weight, patients undergoing AGB lost 10.6% (95% CI, 0.6%-20.6%), and patients undergoing SG lost 17.8% (95% CI, 9.7%-25.9%). Patients undergoing RYGB lost 16.9% (95% CI, 6.2%-27.6%) more of their baseline weight than patients undergoing AGB and 9.7% (95% CI, 0.8%-18.6%) more than patients undergoing SG.Patients in the Veterans Administration health care system lost substantially more weight than nonsurgical matches and sustained most of this weight loss in the long term. Roux-en-Y gastric bypass induced significantly greater weight loss among veterans than SG or AGB at 4 years. These results provide further evidence of the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations.
Project description:Limited data guide the prediction of weight loss success or failure after bariatric surgery according to presurgery factors. There is significant variation in weight change after bariatric surgery and much interest in identifying preoperative factors that may contribute to these differences. This report evaluates the associations of a comprehensive set of baseline factors and 3-year weight change.Ten hospitals in 6 geographically diverse clinical centers in the United States.Adults undergoing a first bariatric surgical procedure as part of clinical care by participating surgeons were recruited between 2006 and 2009. Participants completed research assessments utilizing standardized and detailed data collection on over 100 preoperative and operative parameters for individuals undergoing Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB). Weight was measured 3 years after surgery. Percent weight change for RYGB or LAGB from baseline to 3 years was analyzed as both a continuous and dichotomous outcome with cut points at 25% for RYGB and 10% for LAGB. Multivariable linear and logistic regression models were used to identify independent baseline predictors of the continuous and categorical outcomes, respectively.The median weight loss 3 years after surgery for RYGB (n = 1513) participants was 31.5% (IQR: 24.6%-38.4%; range, 59.2% loss to .9% gain) of baseline weight and 16.0% (IQR: 8.1%-23.1%; range, 56.1% loss to 12.5% gain) for LAGB (n = 509) participants. The median age was 46 years for RYGB and 48 years for LAGB; 80% of RYGB participants and 75% of LAGB participants were female; and the median baseline body mass index (BMI) was 46 kg/m(2) for RYGB and 44 kg/m(2) for LAGB. For RYGB, black participants lost 2.7% less weight compared with whites and participants with diabetes at baseline had 3.7% less weight loss at year 3 than those without diabetes at baseline. There were small but statistically significant differences in weight change for RYGB in those with abnormal kidney function and current or recent smoking. For LAGB participants, those with a large band circumference had 75% greater odds of experiencing less than 10% weight loss after adjusting for BMI and sex.Few baseline variables were associated with 3-year weight change and the effects were small. These results indicate that baseline variables have limited predictive value for an individual's chance of a successful weight loss outcome after bariatric surgery.NCT00465829, ClinicalTrials.gov.
Project description:Severe obesity (body mass index [BMI] ?35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations.To report 3-year change in weight and select health parameters after common bariatric surgical procedures.The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery.Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed.At baseline, participants (N?=?2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%).Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes.clinicaltrials.gov Identifier: NCT00465829.
Project description:Middle-aged women are at a higher risk of being obese. We examined the trajectory of post-surgical % total weight loss (%TWL) among middle-aged female bariatric patients. We fitted sequential generalized estimating equations models to analyze a sample of women who received bariatric surgery in 1995-2012, aged 40-65 years at the time of surgery (N = 158,292) whose pre-operative body mass index (BMI) was ? 30 kg/m2 in the Bariatric Outcomes Longitudinal Database. The %TWL computed by 100% × (pre-surgery BMI - post-surgery BMI) / pre-surgery BMI showed different trajectories depending on type of surgery. For gastric banding, %TWL increased rapidly right after bariatric surgery and started to decrease around 1 year after surgery. For Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, %TWL overall did not show remarkable changes from around 1 year after surgery. The highest increase in %TWL was observed in patients whose pre-operative BMI was 40 or higher and those who had undergone RYGB (ps < 0.001). Whereas the trajectories of %TWL among patients with sleeve gastrectomy and gastric banding did not differ much between different pre-operative BMI groups, the trajectories for RYGB were notably different between different pre-operative BMI groups (ps < 0.001). Middle-aged female bariatric patients are likely to achieve the highest %TWL if they receive RYGB and if their pre-operative BMI is 40 or higher. Further research is warranted to corroborate the present study's finding on the long-term effect of different types of bariatric surgery on %TWL among middle-aged women.