Dataset Information

Ten-year Outcomes of a Prospective Randomized Trial of Laparoscopic Gastric Bypass Versus Laparoscopic Gastric Banding.

ABSTRACT: OBJECTIVE:The primary endpoints of this study were long-term weight loss, morbidity, and changes in comorbidities and quality of life. BACKGROUND:Bariatric surgery is an effective option for the treatment of severe obesity and its related comorbidities. However, few studies have reported on the long-term outcome (>5 yrs) of bariatric surgery. METHODS:Between 2002 and 2007, 250 patients with a body mass index (BMI) of 35 to 60?kg/m were randomly assigned to undergo laparoscopic gastric bypass or laparoscopic gastric banding. After exclusions, 111 patients underwent gastric bypass and 86 patients underwent gastric banding. Factors predictive of improved weight loss were analyzed using multiple logistic regressions. RESULTS:At baseline, the mean age was 43?±?10 years and the mean BMI was 46.5?±?5.6?kg/m. At 10-year follow-up, the mean total body weight loss for the entire cohort was -37.5?±?19.4?kg, -42.4?±?19.6?kg for gastric bypass versus -27.4?±?14.5?kg for gastric banding. Late reoperation was significantly higher after gastric banding compared with the gastric bypass group (31.4% vs. 8.1%, respectively, P < 0.01). For the entire cohort, improvement or remission of diabetes occurred in 68%; 61% for hypertension; and 57% for dyslipidemia. The long-term mortality for the entire cohort was 1.0% at a mean follow-up of 9.5?±?0.4 years. Factors predictive of improved weight loss included the type of operation (ie, gastric bypass), female sex, and the absence of diabetes at baseline. At long-term follow-up, quality of life continues to be improved from baseline for both the groups. CONCLUSIONS:Bariatric surgery is an effective treatment for severe obesity with durable 10-year weight loss and improvement in comorbidities and quality of life. Compared with gastric banding, gastric bypass was associated with better long-term weight loss, lower rate of late reoperation, and improved remission of comorbidities.

SUBMITTER: Nguyen NT

PROVIDER: S-EPMC5867269 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Ten-year Outcomes of a Prospective Randomized Trial of Laparoscopic Gastric Bypass Versus Laparoscopic Gastric Banding.

Nguyen Ninh T NT Kim Eric E Vu Stephen S Phelan Michael M

Annals of surgery 20180701 1

<h4>Objective</h4>The primary endpoints of this study were long-term weight loss, morbidity, and changes in comorbidities and quality of life.<h4>Background</h4>Bariatric surgery is an effective option for the treatment of severe obesity and its related comorbidities. However, few studies have reported on the long-term outcome (>5 yrs) of bariatric surgery.<h4>Methods</h4>Between 2002 and 2007, 250 patients with a body mass index (BMI) of 35 to 60 kg/m were randomly assigned to undergo laparosco ...[more]

PMID: 28692476

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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:BackgroundLaparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up.MethodsBetween March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842).ResultsIn total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) -10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI -10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI -11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4).ConclusionsLaparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 10-year follow-up.

Dataset Information

Ten-year Outcomes of a Prospective Randomized Trial of Laparoscopic Gastric Bypass Versus Laparoscopic Gastric Banding.

Publications

Ten-year Outcomes of a Prospective Randomized Trial of Laparoscopic Gastric Bypass Versus Laparoscopic Gastric Banding.

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