Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial.

IMPORTANCE Venous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking. OBJECTIVE To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery. DESIGN, SETTING, AND PARTICIPANTS This assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland. INTERVENTION Patients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis). MAIN OUTCOMES AND MEASURES The primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality. RESULTS Of 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03522259

Randomized, double-blind, placebo-controlled crossover trial of once daily empagliflozin 25 mg for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass.

Aims To investigate the effect of empagliflozin on glucose dynamics in individuals suffering from postbariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass (RYGB). Methods Twenty-two adults with PBH after RYGB were randomized to empagliflozin 25 mg or placebo once daily over 20 days in a randomized, double-blind, placebo-controlled, crossover trial. The primary efficacy outcome was the amplitude of plasma glucose excursion (peak to nadir) during a mixed meal tolerance test (MMTT). Outcomes of the outpatient period were assessed using continuous glucose monitoring (CGM) and an event-tracking app. Results The amplitude of glucose excursion during the MMTT was 8.1±2.4 mmol/L with empagliflozin vs 8.1±2.6 mmol/L with placebo (mean±SD, p=0.807). CGM-based mean amplitude of glucose excursion (MAGE) during the 20 day-period was lower with empagliflozin than placebo (4.8±1.3 vs 5.2±1.6. p=0.028). Empagliflozin reduced the time spent with CGM values >10.0 mmol/L (3.8±3.5 % vs. 4.7±3.8 %, p =0.009), but not the time spent with CGM values <3.0 mmol/L (1.7±1.6 % vs. 1.5±1.5 %, p=0.457). No significant difference was observed in the quantity and quality of recorded symptoms. Eleven adverse events occurred with empagliflozin (three drug-related) and six with placebo. Conclusions Empagliflozin 25 mg reduces glucose excursions but not hypoglycaemia in individuals with PBH

Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Once Daily Empagliflozin 25 mg for the Treatment of Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass

Aims: To investigate the effect of empagliflozin on glucose dynamics in individuals suffering from postbariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass (RYGB). Methods: Twenty-two adults with PBH after RYGB were randomized to empagliflozin 25 mg or placebo once daily over 20 days in a randomized, double-blind, placebo-controlled, crossover trial. The primary efficacy outcome was the amplitude of plasma glucose excursion (peak to nadir) during a mixed-meal tolerance test (MMTT). Outcomes of the outpatient period were assessed using continuous glucose monitoring (CGM) and an event-tracking app. Results: The amplitude of glucose excursion during the MMTT was 8.1 ± 2.4 mmol/L with empagliflozin versus 8.1 ± 2.6 mmol/L with placebo (mean ± standard deviation, P = 0.807). CGM-based mean amplitude of glucose excursion during the 20-day period was lower with empagliflozin than placebo (4.8 ± 1.3 vs. 5.2 ± 1.6. P = 0.028). Empagliflozin reduced the time spent with CGM values >10.0 mmol/L (3.8 ± 3.5% vs. 4.7 ± 3.8%, P = 0.009), but not the time spent with CGM values <3.0 mmol/L (1.7 ± 1.6% vs. 1.5 ± 1.5%, P = 0.457). No significant difference was observed in the quantity and quality of recorded symptoms. Eleven adverse events occurred with empagliflozin (three drug-related) and six with placebo. Conclusions: Empagliflozin 25 mg reduces glucose excursions but not hypoglycemia in individuals with PBH

Insufficient weight loss after banded vs. non-banded primary gastric bypass surgery: insights from an observational 5 year follow-up study

Background: While Roux-en-Y gastric bypass (RYGB) is effective in achieving weight loss and improving obesity-related co-morbidities, insufficient weight loss in the long-term can occur. The goal was to assess whether banded vs. non-banded RYGB reduces the risk of insufficient weight loss at 5-year follow-up. Methods: This is a retrospective single-center cohort study from Switzerland. We assessed the 5-year metabolic trajectories in terms of body weight, body mass index, glucose control, lipid profile and blood pressure of two surgical cohorts undergoing identical RYGB procedures with or without banding using a uniform 6.5 cm silastic Fobi band. Insufficient weight loss was defined as < 50% excess weight loss (EWL) at 5 years. Results: A total of 55 patients receiving banded (Fobi) and 55 patients receiving non-banded (non-Fobi) RYGB were included in the analysis. 5-year follow-up was 91% for both groups. Percentage of EWL at 5 years was 78.11 ± 26.1% and 73.5 ± 27%.3 for the Fobi vs. non-Fobi group (p = 0.368), respectively. Insufficient weight loss (defined as < 50%EWL) at 5 years or last follow-up was significantly higher in the non-Fobi group compared to the Fobi group (19/55 vs. 9/55, respectively, OR = 2.639 (95% CI 1.066, 6.531), p = 0.036). Surrogate markers for cardiometabolic outcomes consistently improved over time, without differences between the groups. During the follow-up period, Fobi-removal was necessary in nine patients (16.3%). Conclusion: Banded-RYGB lowered the odds of insufficient weight loss at 5 years follow-up by approximately 62%. Further research is needed to explore the effect of restriction on eating behaviour and neuroendocrine responses after RYGB

Fostering physical activity-related health competence after bariatric surgery with a multimodal exercise programme: A randomised controlled trial.

Regular physical activity (PA) supports the long-term success of bariatric surgery. However, integrating health-enhancing physical activity in daily life requires specific competences. In this study, we evaluated a multimodal exercise programme to build these competences.Forty adults who underwent bariatric surgery were randomised to a multimodal exercise programme or control group. Primary outcomes were the facets of PA-related health competences, namely the control competence for physical training, PA-specific affect regulation, motivational competence and PA-specific self-control. Secondary outcomes were PA behaviour and subjective vitality. Outcomes were assessed before, directly after the intervention and at 3 months follow-up.Significant treatment effects were found for control competence for physical training and PA-specific self-control but not for PA-specific affect regulation and motivational competence. Significant treatment effects were further observed for self-reported exercise and subjective vitality, all in favour of the intervention group. In contrast, no treatment effect was found for device-based PA. Overall, this study provides a foundation for future research to optimise long-term post bariatric surgery outcomes

The impact of postbariatric hypoglycaemia on driving performance: A randomized, single-blind, two-period, crossover study in a driving simulator

Postbariatric hypoglycemia (PBH) is an increasingly recognized complication of bariatric surgery, but its effect on daily functioning remains unclear. In this randomized single-blind crossover trial we assessed driving performance in patients with PBH. Ten active drivers with PBH (8 females, age 38.2 ± 14.7 years, BMI 27.2 ± 4.6 kg/m2) received 75 g glucose to induce PBH in the late postprandial period and aspartame to leave glycemia unchanged, on two different occasions. A simulator was driven during 10 min before (D0) and 20 (D1), 80 (D2), 125 (D3) and 140 min (D4) after the glucose/aspartame ingestion, reflecting the expected blood glucose (BG) increase (D1), decrease (D2), and hypoglycemia (D3, D4). Seven driving features indicating impaired driving were integrated in a Bayesian hierarchical regression model to assess the difference in driving performance after glucose/aspartame ingestion. Mean ± standard deviation peak and nadir BG after glucose were 182 ± 24 and 47 ± 14 mg/dL, while BG was stable after aspartame (85 ± 4 mg/dL). Despite the lack of a difference in symptom perception, driving performance was significantly impaired after glucose vs. aspartame during D4 (posterior probability 98.2%). Our findings suggest that PBH negatively affects driving performance.ISSN:1462-8902ISSN:1463-132

Toward the Standardization of Biochar Analysis: The COST Action TD1107 Interlaboratory Comparison

Biochar produced by pyrolysis of organic residues is increasingly used for soil amendment and many other applications. However, analytical methods for its physical and chemical characterization are yet far from being specifically adapted, optimized, and standardized. Therefore, COST Action TD1107 conducted an interlaboratory comparison in which 22 laboratories from 12 countries analyzed three different types of biochar for 38 physical–chemical parameters (macro- and microelements, heavy metals, polycyclic aromatic hydrocarbons, pH, electrical conductivity, and specific surface area) with their preferential methods. The data were evaluated in detail using professional interlaboratory testing software. Whereas intralaboratory repeatability was generally good or at least acceptable, interlaboratory reproducibility was mostly not (20% < mean reproducibility standard deviation < 460%). This paper contributes to better comparability of biochar data published already and provides recommendations to improve and harmonize specific methods for biochar analysis in the future.ISSN:0021-8561ISSN:1520-511