Dataset Information

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

ABSTRACT: 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.

SUBMITTER: Roebroek YGM

PROVIDER: S-EPMC6350363 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

Roebroek Y G M YGM Paulus G F GF van Mil E G A H EGAH Vreugdenhil A C E ACE Winkens B B Nederkoorn C C Stehouwer C D A CDA Greve J W M JWM Bouvy N D ND van Heurn L W E LWE

BMC pediatrics 20190128 1

<h4>Background</h4>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 retro ...[more]

PMID: 30691442

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Project description:IMPORTANCE:There is conflicting evidence about how different bariatric procedures impact health care use. OBJECTIVE:To compare the impact of laparoscopic adjustable gastric banding (AGB) and laparoscopic Roux-en-Y gastric bypass (RYGB) on health care use and costs. DESIGN, SETTING, AND PARTICIPANTS:Retrospective interrupted time series with comparison series study using a national claims data set. The data analysis was initiated in September 2011 and completed in January 2015. We identified bariatric surgery patients aged 18 to 64 years who underwent a first AGB or RYGB between 2005 and 2011. We propensity score matched 4935 AGB to 4935 RYGB patients according to baseline age group, sex, race/ethnicity, socioeconomic variables, comorbidities, year of procedure and baseline costs, emergency department (ED) visits, and hospital days. Median postoperative follow-up time was 2.5 years. MAIN OUTCOMES AND MEASURES:Quarterly and yearly total health care costs, ED visits, hospital days, and prescription drug costs. We used segmented regression to compare pre-to-post changes in level and trend of these measures in the AGB vs the RYGB groups and difference-in-differences analysis to estimate the magnitude of difference by year. RESULTS:Both AGB and RYGB were associated with downward trends in costs; however, by year 3, AGB patients had total annual costs that were 16% higher than RYGB patients (P < .001; absolute change: $818; 95% CI, $278 to $1357). In postoperative years 1 and 2, AGB was associated with 27% to 29% fewer ED visits than RYGB (P < .001; absolute changes: -0.6; 95% CI, -0.9 to -0.4 and -0.4; 95% CI, -0.6 to -0.1 visits/person, respectively); however, by year 3, there were no detectable differences. Postoperative annual hospital days were not significantly different between the groups. Although both procedures lowered prescription costs, annual postoperative prescription costs were 17% to 32% higher for AGB patients than RYGB patients (P < .001). CONCLUSIONS AND RELEVANCE:Both laparoscopic AGB and RYGB were associated with flattened total health care cost trajectories but RYGB patients experienced lower total and prescription costs by 3 years postsurgery. On the other hand, RYGB was associated with increased ED visits in the 2 years after surgery. Clinicians and policymakers should weigh such differences in use and costs when making recommendations or shaping regulatory guidance about these procedures.

Project description:Importance:Bariatric surgery is an effective and safe approach for weight loss and short-term improvement in metabolic disorders such as diabetes. However, studies have been limited in most settings by lack of a nonsurgical group, losses to follow-up, missing data, and small sample sizes in clinical trials and observational studies. Objective:To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients. Design, Setting, and Participants:Retrospective cohort study in a large Israeli integrated health fund covering 54% of Israeli citizens with less than 1% turnover of members annually. Obese adult patients who underwent bariatric surgery between January 1, 2005, and December 31, 2014, were selected and compared with obese nonsurgical patients matched on age, sex, body mass index (BMI), and diabetes, with a final follow-up date of December 31, 2015. A total of 33 540 patients were included in this study. Exposures:Bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) or usual care obesity management only (provided by a primary care physician and which may include dietary counseling and behavior modification). Main Outcomes and Measures:The primary outcome, all-cause mortality, matched and adjusted for BMI prior to surgery, age, sex, socioeconomic status, diabetes, hyperlipidemia, hypertension, cardiovascular disease, and smoking. Results:The study population included 8385 patients who underwent bariatric surgery (median age, 46 [IQR, 37-54] years; 5490 [65.5%] women; baseline median BMI, 40.6 [IQR, 38.5-43.7]; laparoscopic banding [n = 3635], gastric bypass [n = 1388], laparoscopic sleeve gastrectomy [n = 3362], and 25 155 nonsurgical matched patients (median age, 46 [IQR, 37-54] years; 16 470 [65.5%] women; baseline median BMI, 40.5 [IQR, 37.0-43.5]). The availability of follow-up data was 100% for all-cause mortality. There were 105 deaths (1.3%) among surgical patients during a median follow-up of 4.3 (IQR, 2.8-6.6) years (including 61 [1.7%] who underwent laparoscopic banding, 18 [1.3%] gastric bypass, and 26 [0.8%] sleeve gastrectomy), and 583 deaths (2.3%) among nonsurgical patients during a median follow-up of 4.0 (IQR, 2.6-6.2) years. The absolute difference was 2.51 (95% CI, 1.86-3.15) fewer deaths/1000 person-years in the surgical vs nonsurgical group. Adjusted hazard ratios (HRs) for mortality among nonsurgical vs surgical patients were 2.02 (95% CI, 1.63-2.52) for the entire study population; by surgical type, HRs were 2.01 (95% CI, 1.50-2.69) for laparoscopic banding, 2.65 (95% CI, 1.55-4.52) for gastric bypass, and 1.60 (95% CI, 1.02-2.51) for laparoscopic sleeve gastrectomy. Conclusions and Relevance:Among obese patients in a large integrated health fund in Israel, bariatric surgery using laparoscopic banding, gastric bypass, or laparoscopic sleeve gastrectomy, compared with usual care nonsurgical obesity management, was associated with lower all-cause mortality over a median follow-up of approximately 4.5 years. The evidence of this association adds to the limited literature describing beneficial outcomes of these 3 types of bariatric surgery compared with usual care obesity management alone.

Project description:Elevated rates of psychopathology are noted among severely obese youth presenting for weight loss surgery. The role of mental health providers in this population is not well defined, and the selection of candidates is often the result of clinical judgment alone. The purpose of this study was to comprehensively evaluate psychiatric symptoms among a large sample of adolescents receiving laparoscopic adjustable gastric banding (LAGB) by (1) examining changes in depressive symptoms and quality of life in the year following surgery; (2) evaluating the interaction between patterns of change in depression, quality of life, and weight postsurgery; and (3) identifying presurgical psychological predictors of initial weight change.Participants were 101 severely obese adolescents aged 14 to 18 years receiving LAGB at the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children's Hospital of New York Presbyterian/Columbia University Medical Center between August 2006 and December 2009. Measures of height, weight, depressive symptoms, and quality of life were obtained in the first year following surgery. Changes in the Beck Depression Inventory (BDI), Pediatric Quality of Life Inventory (PedsQL), and body mass index were analyzed using latent growth curve modeling.Short-term changes in psychiatric symptoms and weight were analyzed using latent growth curve modeling. Significant changes in total BDI (?slope = -0.885, SE = 0.279, P < .01; ?quadratic = 0.054, SE = 0.021, P < .001) and PedsQL (?slope = -0.885, SE = 0.279, P < .001) scores were observed following LAGB, and comparable postoperative changes between psychosocial variables and body mass index were also noted (BDI: covariance [COV] = 0.21, SE = 0.06, P < .001; PedsQL: COV = -0.41, SE = 0.10, P < .01). Two variables (family conflict/loss of control eating) were found to be significant predictors of weight change over the year following surgery (P < .05).Adolescents experienced notable improvements in initial depressive symptoms and quality of life after LAGB, and measures of preoperative binge eating and family conflict affected postsurgery body mass index among youth.ClinicalTrials.gov identifier: NCT01045499.

Dataset Information

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

Publications

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

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