35 research outputs found

    Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

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    In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized

    What Is Weight Loss After Bariatric Surgery Expressed in Percentage Total Weight Loss (%TWL)? A Systematic Review

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    Percentage total weight loss (%TWL) might be better than percentage excess weight loss to express weight loss in bariatric surgery. In this systematic review, performed according to the PRISMA statement, results of laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB) are assessed in %TWL. A total of 13,426 studies were screened and 49 included, reporting data of 24,760 patients. The results show that, despite limiting data, LRYGB is favorable over LSG in terms of weight loss in short-term follow-up. Although recent guidelines recommend to use %TWL when reporting outcome in bariatric surgery, this study shows that there is still insufficient quality data in %TWL, especially on LSG. The use of %TWL as the primary outcome measure in bariatric surgery should be encouraged. Graphical abstract: [Figure not available: see fulltext.]

    Reporting Weight Loss 2021: Position Statement of the Dutch Society for Metabolic and Bariatric Surgery (DSMBS)

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    Prevailing recommendations on reporting weight loss after bariatric and metabolic surgery are not evidence-based. They promote the outcome metric percentage excess weight loss (%EWL), sometimes indicated as percentage excess body mass index loss (%EBMIL). Many studies proved that this popular outcome measure, in contrast to other weight loss metrics, is inaccurate and error-sensitive when comparing weight loss within and between studies. It is inappropriate for assessing poor weight loss response and weight regain as well. The percentage (total) weight loss metric is the best alternative. The Dutch Society for Metabolic and Bariatric Surgery (DSMBS) recommends to stop using the %EWL (or %EBMIL) metric as primary outcome measure in all cases and calls on the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) to propagate this evidence-based recommendation. Graphical Abstract: [Figure not available: see fulltext.

    Interpretation of laboratory results after gastric bypass surgery: the effects of weight loss and time on 30 blood tests in a 5-year follow-up program

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    Background: Long-term follow-up with blood tests is essential for bariatric surgery to be a successful treatment for obesity and related co-morbidities. Adverse effects, deficiencies, and metabolic improvements need to be controlled. Objective: We investigated the effects of time and weight loss on laboratory results in each postoperative phase after laparoscopic Roux-en-Y gastric bypass (LRYGB). Setting: Bariatric center of excellence, general hospital, Netherlands. Methods: We retrospectively evaluated results of 30 blood tests, preoperatively and at 6 months, 1 year, 2 years, and 5 years after LRYGB. The 2019 Dutch bariatric chart was used to define weight loss responses as outstanding (>p[percentile curve]+1 SD), average (p+1 SD to p−1 SD), and poor (<p−1 SD). Results are presented with fifth and 95th percentile cutoff values per blood test for each of these 3 weight loss responses at each of the 4 postoperative time intervals. We used ANOVA to determine mutual relations. Results: Results of 4835 patients were analyzed. Five-year follow-up was 58%. Blood levels of ferritin, mean-corpuscular-volume, thrombocytes, vitamin D, parathyroid-hormone, glycated hemoglobin (HbA1C), triglyceride, total-cholesterol, C-reactive-protein, gamma-glutamyl-transferase, alkaline-phosphatase, creatinine, vitamin B1, and total protein were related with weight loss response. All 30 blood tests were also related with time. For several blood tests, weight loss and time did not only influence median results, but also fifth and 95th percentile cutoff values. Many patients had better vitamin levels after the operation. We observed an increase of parathyroid-hormone and ongoing iron depletion up to 5 years post surgery. Conclusions: Presenting results of 30 routine blood tests, including cutoff values based on fifth and 95th percentile, grouped by weight loss response and postoperative time interval after gastric bypass surgery is new. The elaborate tables and graphs could serve as practical guide for proper interpretation of laboratory results in postbariatric surveillance. Results underline the need for long-term follow-up, including blood tests

    Interpretation of laboratory results after gastric bypass surgery: the effects of weight loss and time on 30 blood tests in a 5-year follow-up program

    No full text
    Background: Long-term follow-up with blood tests is essential for bariatric surgery to be a successful treatment for obesity and related co-morbidities. Adverse effects, deficiencies, and metabolic improvements need to be controlled. Objective: We investigated the effects of time and weight loss on laboratory results in each postoperative phase after laparoscopic Roux-en-Y gastric bypass (LRYGB). Setting: Bariatric center of excellence, general hospital, Netherlands. Methods: We retrospectively evaluated results of 30 blood tests, preoperatively and at 6 months, 1 year, 2 years, and 5 years after LRYGB. The 2019 Dutch bariatric chart was used to define weight loss responses as outstanding (>p[percentile curve]+1 SD), average (p+1 SD to p−1 SD), and poor (<p−1 SD). Results are presented with fifth and 95th percentile cutoff values per blood test for each of these 3 weight loss responses at each of the 4 postoperative time intervals. We used ANOVA to determine mutual relations. Results: Results of 4835 patients were analyzed. Five-year follow-up was 58%. Blood levels of ferritin, mean-corpuscular-volume, thrombocytes, vitamin D, parathyroid-hormone, glycated hemoglobin (HbA1C), triglyceride, total-cholesterol, C-reactive-protein, gamma-glutamyl-transferase, alkaline-phosphatase, creatinine, vitamin B1, and total protein were related with weight loss response. All 30 blood tests were also related with time. For several blood tests, weight loss and time did not only influence median results, but also fifth and 95th percentile cutoff values. Many patients had better vitamin levels after the operation. We observed an increase of parathyroid-hormone and ongoing iron depletion up to 5 years post surgery. Conclusions: Presenting results of 30 routine blood tests, including cutoff values based on fifth and 95th percentile, grouped by weight loss response and postoperative time interval after gastric bypass surgery is new. The elaborate tables and graphs could serve as practical guide for proper interpretation of laboratory results in postbariatric surveillance. Results underline the need for long-term follow-up, including blood tests

    Can a laparoscopic Roux-en-Y gastric bypass be safely performed by surgical residents in a bariatric center-of-excellence? The learning curve of surgical residents in bariatric surgery

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    Background A learning curve (LC) is a graphic display of the number of consecutive procedures performed necessary to reach competence and is defined by complications and duration of surgery (DOS). There is little evidence on the LC of surgical residents in bariatric surgery. Aim of the study is to evaluate whether the laparoscopic Roux-en-Y gastric bypass (LRYGB) can be safely performed by surgical residents, to evaluate the LC of surgical residents for LRYGB and to assess whether surgical residents fit in the LC of the bariatric center which has been established by their proctors. Methods Records of all 3389 consecutive primary LRYGB patients, operated between December 2007 and January 2016 in a bariatric center-of-excellence in Amsterdam, were reviewed. Differences in DOS were assessed by means of a linear regression model. Differences in complications (classified as Clavien-Dindo >= 2) were evaluated with the chi(2) or the Fisher exact test. Cases were clustered in groups of 70 for comparison and reported for residents with >= 70 cases as primary surgeon. Results Four surgeons (S1-4) and three residents (R1-3) performed 2690 (88.2%) and 361 (11.8%) of 3051 LRYGBs, respectively. Median (IQR) DOS was 52.0 (42.0-65.0) min for S1-4 versus 53.0 (46.0-63.0) min for R1-3 (p = 0.52). The LC of R1-3 in their first 70 cases (n = 210) differs significantly from the individual (n = 70) LCs of surgeon 1, 2, and 3, with remarkably shorter DOS for the residents (adjusted p <0.0001; p <0.001 and p = 0.0002, respectively) and the same amount of surgical complications 5.1% (137/2690) for S1-4 versus 3.0% (11/361) for R1-3 (p = 0.089). Conclusion Laparoscopic Roux-en-Y gastric bypass can be safely performed by surgical residents under supervision of experienced bariatric surgeons. Surgical residents benefit from the experience of their proctors and they fit faultlessly in the LC of the surgical team, as set out by their proctors in a large bariatric center-of-excellenc

    Gastrointestinal symptoms before and after laparoscopic Roux-en-Y gastric bypass: a longitudinal assessment

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    Background: Roux-en-Y gastric bypass (RYGB)is an effective treatment for morbid obesity, but many patients have increased gastrointestinal symptoms. Objectives: To evaluate gastrointestinal symptoms and food intolerance before and after RYGB over time in a large cohort of morbidly obese patients. Setting: A high-volume bariatric center of excellence. Methods: A prospective cohort study was performed in patients who underwent RYGB between September 2014 and July 2015, with 2-year follow-up. Consecutive patients screened for bariatric surgery answered the Gastrointestinal Symptom Rating Scale (GSRS)and a food intolerance questionnaire before RYGB and 2 years after surgery. The prevalence of gastrointestinal symptoms before and after surgery and the association between patient characteristics and postoperative gastrointestinal symptoms were assessed. Results: Follow-up was 86.2% (n = 168)for patients undergoing primary RYGB and 93.3% (n = 28)for revisional RYGB. The total mean GSRS score increased from 1.69 to 2.31 after surgery (P <.001), as did 13 of 16 of the individual scores. Preoperative GSRS score is associated with postoperative symptom severity (B =.343, P <.001). Food intolerance was present in 16.1% of patients before primary RYGB, increasing to 69.6% after surgery (P <.001). Patients who underwent revisional RYGB had a symptom severity and prevalence of food intolerance comparable with that among patients with primary RYGB, even though they had more symptoms before revisional surgery. Conclusions: Two years after surgery, patients who underwent primary RYGB have increased gastrointestinal symptoms and food intolerance compared with the preoperative state. It is important that clinicians are aware of this and inform patients before surgery

    Fixed-dose enoxaparin after bariatric surgery: the influence of body weight on peak anti-xa levels

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    There is lack of data on the pharmacodynamics of low-molecular-weight heparins in obese patients. The aims of this study are to investigate the correlation between anti-factor Xa (anti-Xa) levels and body weight with fixed-dose enoxaparin after bariatric surgery and to investigate the percentage of patients that reach the desired prophylactic range for anti-Xa levels. Blood for anti-Xa peak levels measurement was drawn 3-5 h after administration of enoxaparin at the planned visit 8-16 days after surgery. Patients were included in three categories: 150 kg (group 3). Fifty-one patients were included (43.9 ± 9.9 years, 75 % women). Mean anti-Xa level was 0.37 ± 0.14 IU/ml. This level was the highest in group 1 (0.47 ± 0.13 IU/ml) and lowest in group 3 (0.23 ± 0.07). No subprophylactic ( 0.5 IU/ml) were most often present in group 1 (36 %). With multivariable regression analysis, body weight (β -0.720 (95 % confidence interval -.717; -.993), p  < 0.001) was an independent predictor of anti-Xa levels, whereas lean body was not independently associated. This was confirmed in a non-linear mixed effects analysis of the data. Patients with excessive body weight may not be adequately treated with fixed-dose enoxaparin thromboprophylaxis while patients with lower body weight may have an increased bleeding risk. Body weight is a better predictor of anti-Xa levels compared to lean body weigh

    Ursodeoxycholic Acid Use After Bariatric Surgery: Effects on Metabolic and Inflammatory Blood Markers

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    Background: In addition to the reduction of symptomatic gallstone disease, ursodeoxycholic acid (UDCA) might also have beneficial metabolic effects after bariatric surgery. We examined the impact of UDCA on liver enzymes, hemoglobin A1c (HbA1c), lipids, and inflammation markers. Methods: Patients in the UPGRADE trial (placebo-controlled, double-blind) were randomized between UDCA 900 mg daily or placebo pills for 6 months after bariatric surgery. Patients without blood measurements pre- or 6 months postoperatively were excluded. The change in liver enzymes, Hba1c, lipids, and inflammation markers after surgery were compared between the UDCA and placebo group, followed by a postoperative cross-sectional comparison. Results: In total, 513 patients were included (age [mean ± SD] 45.6 ± 10.7 years; 79% female). Preoperative blood values did not differ between UDCA (n = 266) and placebo (n = 247) groups. Increase of alkaline phosphatase (ALP) was greater in the UDCA group (mean difference 3.81 U/l [95%CI 0.50 7.12]). Change in other liver enzymes, HbA1c, lipids, and CRP levels did not differ. Postoperative cross-sectional comparison in 316 adherent patients also revealed a higher total cholesterol (mean difference 0.25 mg/dl [95%CI 0.07–0.42]), lower aspartate aminotransferase (mean difference −3.12 U/l [−5.16 – −1.08]), and lower alanine aminotransferase level (mean difference −5.89 U/l [−9.41 – −2.37]) in the UDCA group. Conclusion: UDCA treatment leads to a higher, but clinically irrelevant increase in ALP level in patients 6 months after bariatric surgery. No other changes in metabolic or inflammatory markers were observed. Except for the reduction of gallstone formation, UDCA has no effects after bariatric surgery. Graphical Abstract: [Figure not available: see fulltext.]
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