| 1. |
- Bruze, Gustaf, et al.
(författare)
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Associations of Bariatric Surgery With Changes in Interpersonal Relationship Status Results From 2 Swedish Cohort Studies
- 2018
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Ingår i: JAMA Surgery. - : American Medical Association. - 2168-6254 .- 2168-6262. ; 153:7, s. 654-661
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: Bariatric surgery is a life-changing treatment for patients with severe obesity, but little is known about its association with interpersonal relationships.OBJECTIVES: To investigate if relationship status is altered after bariatric surgery.DESIGN, SETTING, AND PARTICIPANTS: Changes in relationship status after bariatric surgery were examined in 2 cohorts: (1) the prospective Swedish Obese Subjects (SOS) study, which recruited patients undergoing bariatric surgery from September 1, 1987, to January 31, 2001, and compared their care with usual nonsurgical care in matched obese control participants; and (2) participants from the Scandinavian Obesity Surgery Registry (SOReg), a prospective, electronically captured register that recruited patients from January 2007 through December 2012 and selected comparator participants from the general population matched on age, sex, and place of residence. Data was collected in surgical departments and primary health care centers in Sweden. The current analysis includes data collected up until July 2015 (SOS) and December 2012 (SOReg). Data analysis was completed from June 2016 to December 2017.MAIN OUTCOMES AND MEASURES: In the SOS study, information on relationship status was obtained from questionnaires. In the SOReg and general population cohort, information on marriage and divorce was obtained from the Swedish Total Population Registry.RESULTS: The SOS study included 1958 patients who had bariatric surgery (of whom 1389 [70.9%] were female) and 1912 matched obese controls (of whom 1354 [70.8%] were female) and had a median (range) follow-up of 10 (0.5-20) years. The SOReg cohort included 29 234 patients who had gastric bypass surgery (of whom 22 131 [75.6%] were female) and 283 748 comparators from the general population (of whom 214 342 [75.5%] were female), and had a median (range) follow-up of 2.9 (0.003-7.0) years. In the SOS study, the surgical patients received gastric banding (n = 368; 18.8%), vertical banded gastroplasty (n = 1331; 68.0%), or gastric bypass (n = 259; 13.2%); controls received usual obesity care. In SOReg, all 29 234 surgical participants received gastric bypass surgery. In the SOS study, bariatric surgery was associated with increased incidence of divorce/separation compared with controls for those in a relationship (adjusted hazard ratio [aHR] = 1.28; 95% CI, 1.03-1.60; P =.03) and increased incidence of marriage or new relationship (aHR = 2.03; 95% CI, 1.52-2.71; P <.001) in those who were unmarried or single at baseline. In the SOReg and general population cohort, gastric bypass was associated with increased incidence of divorce compared with married control participants (aHR = 1.41; 95% CI, 1.33-1.49; P <.001) and increased incidence of marriage in those who were unmarried at baseline (aHR = 1.35; 95% CI, 1.28-1.42; P <.001). Within the surgery groups, changes in relationship status were more common in those with larger weight loss.CONCLUSIONS AND RELEVANCE: In addition to its association with obesity comorbidities, bariatric surgery-induced weight loss is also associated with changes in relationship status.
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| 2. |
- Claesson, Andreas, et al.
(författare)
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Defibrillation before EMS arrival in western Sweden
- 2017
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Ingår i: American Journal of Emergency Medicine. - : Elsevier. - 0735-6757 .- 1532-8171. ; 35:8, s. 1043-1048
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Bystanders play a vital role in public access defibrillation (PAD) in out-of-hospital cardiac arrest (OHCA). Dual dispatch of first responders (FR) alongside emergency medical services (EMS) can reduce time to first defibrillation. The aim of this study was to describe the use of automated external defibrillators (AEDs) in OHCAs before EMS arrival.METHODS: All OHCA cases with a shockable rhythm in which an AED was used prior to the arrival of EMS between 2008 and 2015 in western Sweden were eligible for inclusion. Data from the Swedish Register for Cardiopulmonary Resuscitation (SRCR) were used for analysis, on-site bystander and FR defibrillation were compared with EMS defibrillation in the final analysis.RESULTS: Of the reported 6675 cases, 24% suffered ventricular fibrillation (VF), 162 patients (15%) of all VF cases were defibrillated before EMS arrival, 46% with a public AED on site. The proportion of cases defibrillated before EMS arrival increased from 5% in 2008 to 20% in 2015 (p<0.001). During this period, 30-day survival increased in patients with VF from 22% to 28% (p=0.04) and was highest when an AED was used on site (68%), with a median delay of 6.5min from collapse to defibrillation. Adjusted odds ratio for on-site defibrillation versus dispatched defibrillation for 30-day survival was 2.45 (95% CI: 1.02-5.95).CONCLUSIONS: The use of AEDs before the arrival of EMS increased over time. This was associated with an increased 30-day survival among patients with VF. Thirty-day survival was highest when an AED was used on site before EMS arrival.
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| 3. |
- Neovius, Martin, et al.
(författare)
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Risk of suicide and non-fatal self-harm after bariatric surgery: results from two matched cohort studies.
- 2018
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Ingår i: The lancet. Diabetes & endocrinology. - : Elsevier. - 2213-8595 .- 2213-8587. ; 6:3, s. 197-207
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Tidskriftsartikel (refereegranskat)abstract
- Bariatric surgery reduces mortality, but might have adverse effects on mental health. We assessed the risk of suicide and self-harm after bariatric surgery compared with non-surgical obesity treatment.Suicide and non-fatal self-harm events retrieved from nationwide Swedish registers were examined in two cohorts. The non-randomised, prospective Swedish Obese Subjects (SOS) study compared bariatric surgery (n=2010; 1369 vertical-banded gastroplasty, 376 gastric banding, and 265 gastric bypass) with usual care (n=2037; recruitment 1987-2001). The second cohort consisted of individuals from the Scandinavian Obesity Surgery Registry (SOReg; n=20256 patients who had gastric bypass) matched to individuals treated with intensive lifestyle modification (n=16162; intervention 2006-13) on baseline BMI, age, sex, education level, diabetes, cardiovascular disease, history of self-harm, substance misuse, antidepressant use, anxiolytics use, and psychiatric health-care contacts.During 68528 person-years (median 18; IQR 14-21) in the SOS study, suicides or non-fatal self-harm events were higher in the surgery group (n=87) than in the control group (n=49; adjusted hazard ratio [aHR] 1·78, 95% CI 1·23-2·57; p=0·0021); of these events, nine and three were suicides, respectively (3·06, 0·79-11·88; p=0·11). In analyses by primary procedure type, increased risk of suicide or non-fatal self-harm was identified for gastric bypass (3·48, 1·65-7·31; p=0·0010), gastric banding (2·43, 1·23-4·82; p=0·011), and vertical-banded gastroplasty (2·25, 1·37-3·71; p=0·0015) compared with controls. Out of nine deaths by suicide in the SOS surgery group, five occurred after gastric bypass (two primary and three converted procedures). During 149582 person-years (median 3·9; IQR 2·8-5·2), more suicides or non-fatal self-harm events were reported in the SOReg gastric bypass group (n=341) than in the intensive lifestyle group (n=84; aHR 3·16, 2·46-4·06; p<0·0001); of these events, 33 and five were suicides, respectively (5·17, 1·86-14·37; p=0·0017). In SOS, substance misuse during follow-up was recorded in 48% (39/81) of patients treated with surgery and 28% (13/47) of controls with non-fatal self-harm events (p=0·023). Correspondingly, substance misuse during follow-up was recorded in 51% (162/316) of participants in the SOReg gastric bypass group and 29% (23/80) of participants in the intensive lifestyle group with non-fatal self-harm events (p=0·0003). The risk of suicide and self-harm was not associated with poor weight loss outcome.Bariatric surgery was associated with suicide and non-fatal self-harm. However, the absolute risks were low and do not justify a general discouragement of bariatric surgery. The findings indicate a need for thorough preoperative psychiatric history assessment along with provision of information about increased risk of self-harm following surgery. Moreover, the findings call for postoperative surveillance with particular attention to mental health.US National Institutes of Health and Swedish Research Council.
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| 4. |
- Stenberg, Erik, 1979-, et al.
(författare)
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Comparison of Sleeve Gastrectomy vs Intensive Lifestyle Modification in Patients With a BMI of 30 to Less Than 35
- 2022
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Ingår i: JAMA Network Open. - : American Medical Association. - 2574-3805. ; 5:7
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Tidskriftsartikel (refereegranskat)abstract
- Importance: There is a lack of studies evaluating sleeve gastrectomy compared with intensive lifestyle treatment in patients with class 1 obesity (body mass index [BMI] 30 to <35 [calculated as weight in kilograms divided by height in meters squared]).Objective: To compare outcomes and safety of sleeve gastrectomy compared with intensive nonoperative obesity treatment in patients with class 1 obesity.Design, Setting, and Participants: This matched, nationwide cohort study included patients with class 1 obesity who underwent a sleeve gastrectomy or intensive lifestyle treatment between January 1, 2012, and December 31, 2017, and who were registered in the Scandinavian Obesity Surgery Registry or the Itrim health database. Participants with class 1 obesity were matched 1:2 using a propensity score including age, sex, BMI, treatment year, education level, income, cardiovascular disease, and use of antibiotic drugs, antidepressants, and anxiolytics.Interventions: Sleeve gastrectomy or intensive lifestyle treatment.Main Outcomes and Measures: Outcomes included weight loss after intervention, changes in metabolic comorbidities, substance use disorders, self-harm, and major cardiovascular events retrieved from the National Patient Register, Prescribed Drug Register, and Cause of Death Register as well as the Scandinavian Obesity Surgery Registry and the Itrim health database. Data were analyzed from December 1, 2021 until May 31, 2022.Results: The study included 1216 surgery patients and 2432 lifestyle participants with similar mean (SD) BMI (32.8 [1.4] vs 32.9 [1.4]), mean (SD) age (42.4 [9.7] vs 42.6 [12.7] years), and sex (1091 [89.7%] vs 2191 [90.1%] women). Surgery patients had greater 1-year weight loss compared with controls (22.9 kg vs 11.9 kg; mean difference, 10.7 kg; 95% CI, 10.0-11.5 kg; P < .001). Over a median follow-up of 5.1 years (IQR, 3.9-6.2 years), surgery patients had a lower risk of incident use of diabetes drugs (59.7 vs 100.4 events per 10 000 person-years; hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02) and greater 2-year diabetes drug remission (48.4% vs 22.0%; risk difference 26.4%; 95% CI, 11.7%-41.0%; P < .001), but higher risk for substance use disorder (94 vs 50 events per 10 000 person-years; HR, 1.86; 95% CI, 1.30-2.67; P < .001) and self-harm (45 vs 25 events per 10 000 person-years; HR, 1.81; 95% CI, 1.09-3.01; P = .02). No between-group difference in occurrence of major cardiovascular events was observed (23.4 vs 24.8 events per 10 000 person-years; HR, 0.96; 95% CI, 0.49-1.91; P = .92).Conclusions and Relevance: In this cohort study, compared with intensive nonoperative obesity treatment, sleeve gastrectomy in patients with class 1 obesity was associated with greater weight loss, diabetes prevention, and diabetes remission but a higher incidence of substance use disorder and self-harm.
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| 5. |
- Wallén, Stefan, 1978-, et al.
(författare)
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Opioid Use After Gastric Bypass, Sleeve Gastrectomy or Intensive Lifestyle Intervention
- 2023
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Ingår i: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 277:3, s. e552-e560
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To compare opioid use in patients with obesity treated with bariatric surgery versus adults with obesity who underwent intensive lifestyle modification. SUMMARY OFBACKGROUND DATA: Previous studies of opioid use after bariatric surgery have been limited by small sample sizes, short follow-up, and lack of control groups.METHODS: Nationwide matched cohort study including individuals from the Scandinavian Obesity Surgery Registry and the Itrim health database with individuals undergoing structured intensive lifestyle modification, between August 1, 2007 and September 30, 2015. Participants were matched on Body Mass Index, age, sex, education, previous opioid use, diabetes, cardiovascular disease, and psychiatric status (n = 30,359:21,356). Dispensed opioids were retrieved from the Swedish Prescribed Drug Register from 2 years before to up to 8 years after intervention.RESULTS: During the 2-year period before treatment, prevalence of individuals receiving ≥1 opioid prescription was identical in the surgery and lifestyle group. At 3 years, the prevalence of opioid prescriptions was 14.7% versus 8.9% in the surgery and lifestyle groups (mean difference 5.9%, 95% confidence interval 5.3-6.4) and at 8 years 16.9% versus 9.0% (7.9%, 6.8-9.0). The difference in mean daily dose also increased over time and was 3.55 mg in the surgery group versus 1.17 mg in the lifestyle group at 8 years (mean difference [adjusted for baseline dose] 2.30 mg, 95% confidence interval 1.61-2.98).CONCLUSIONS: Bariatric surgery was associated with a higher proportion of opioid users and larger total opioid dose, compared to actively treated obese individuals. These trends were especially evident in patients who received additional surgery during follow-up.
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| 6. |
- Bruze, Gustaf, et al.
(författare)
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Mental health from 5 years before to 10 years after bariatric surgery in adolescents with severe obesity: a Swedish nationwide cohort study with matched population controls
- 2024
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Ingår i: LANCET CHILD & ADOLESCENT HEALTH. - : ELSEVIER SCI LTD. - 2352-4642 .- 2352-4650. ; 8:2, s. 135-146
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Tidskriftsartikel (refereegranskat)abstract
- Background: The long-term effects of bariatric surgery on the mental health of adolescents with severe obesity remain uncertain. We aimed to describe the prevalence of psychiatric health-care visits and filled prescription psychiatric drugs among adolescents with severe obesity undergoing bariatric surgery in the 5 years preceding surgery and throughout the first 10 years after surgery, and to draw comparisons with matched adolescents in the general population. Methods: Adolescents with severe obesity and who underwent bariatric surgery were identified through the Scandinavian Obesity Surgery Registry. We included adolescents who had bariatric surgery between 2007 and 2017 and were younger than 21 years at time of surgery. Each adolescent patient was matched with ten adolescents from the general population by age, sex, and county of residence. Specialist psychiatric care and filled psychiatric prescriptions were retrieved from nationwide data registers. Findings: 1554 adolescents (<21 years) with severe obesity underwent bariatric surgery between 2007 and 2017, 1169 (75%) of whom were female. At time of surgery, the mean age was 19.0 years [SD 1.0], and the mean BMI was 43.7 kg/m(2) (SD 5.5). 15 540 adolescents from the general population were matched with adolescents in the surgery group. 5 years before the matched index date, 95 (6.2%) of 1535 surgery patients and 370 (2.5%) of 14 643 matched adolescents had a psychiatric health-care visit (prevalence difference 3.7%; 95% CI 2.4-4.9), whereas 127 (9.8%) of 1295 surgery patients and 445 (3.6%) of 12 211 matched adolescents filled a psychiatric drug prescription (prevalence difference 6.2%; 95% CI 4.5-7.8). The year before the matched index date, 208 (13.4%) of 1551 surgery patients and 844 (5.5%) of 15 308 matched adolescents had a psychiatric health-care visit (prevalence difference 7.9%; 95% CI 6.2-9.6), whereas 319 (20.6%) of 1551 surgery patients and 1306 (8.5%) of 15 308 matched adolescents filled a psychiatric drug prescription (prevalence difference 12.0%; 10.0-14.1). The prevalence difference in psychiatric health-care visits peaked 9 years after the matched index date (12.0%; 95% CI 9.0-14.9), when 119 (17.6%) of 675 surgery patients and 377 (5.7%) of 6669 matched adolescents had a psychiatric health-care visit. The prevalence difference in filled psychiatric drug prescription was highest 10 years after the matched index date (20.4%; 15.9-24.9), when 171 (36.5%) of 469 surgery patients and 739 (16.0%) of 4607 matched adolescents filled a psychiatric drug prescription. The year before the matched index date, 19 (1.2%) of 1551 surgery patients and 155 (1.0%) of 15304 matched adolescents had a health-care visit associated with a substance use disorder diagnosis (mean difference 0.2%, 95% CI -0.4 to 0.8). 10 years after the matched index date, the prevalence difference had increased to 4.3% (95% CI 2.3-6.4), when 24 (5.1%) of 467 surgery patients and 37 (0.8%) of 4582 matched adolescents had a health-care visit associated with a substance use disorder diagnosis. Interpretation: Psychiatric diagnoses and psychiatric drug prescriptions were more common among adolescents with severe obesity who would later undergo bariatric surgery than among matched adolescents from the general population. Both groups showed an increase in prevalence in psychiatric diagnoses and psychiatric drug prescriptions leading up to the time of surgery, but the rate of increase in the prevalence was higher among adolescents with severe obesity than among matched adolescents. With the exception of health-care visits for substance use disorders, these prevalence trajectories continued in the 10 years of follow-up. Realistic expectations regarding mental health outcomes should be set preoperatively. Funding: Swedish Research Council, Swedish Research Council for Health, Working Life and Welfare.
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| 7. |
- Akerblom, H., et al.
(författare)
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Association of Gastric Bypass Surgery With Risk of Developing Diabetic Retinopathy Among Patients With Obesity and Type 2 Diabetes in Sweden: An Observational Study
- 2021
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Ingår i: Jama Ophthalmology. - : American Medical Association (AMA). - 2168-6165 .- 2168-6173. ; 139:2, s. 200-205
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE Knowledge of the incidence and progression of diabetic retinopathy (DR) after gastric bypass surgery (GBP) in patients with obesity and diabetes could guide the management of these patients. OBJECTIVE To investigate the incidence of diabetic ocular complications in patients with type 2 diabetes after GBP compared with the incidence of diabetic ocular complications in a matched cohort of patients with obesity and diabetes who have not undergone GBP. DESIGN, SETTING, AND PARTICIPANTS Data from 2 nationwide registers in Sweden, the Scandinavian Obesity Surgery Registry and the National Diabetes Register, were used for this cohort study. A total of 5321 patients with diabetes from the Scandinavian Obesity Surgery Registry who had undergone GBP from January 1, 2007, to December 31, 2013, were matched with 5321 patients with diabetes from the National Diabetes Register who had not undergone GBP, based on sex, age, body mass index (BMI), and calendar time (2007-2013). Follow-up data were obtained until December 31, 2015. Statistical analysis was performed from October 5, 2018, to September 30, 2019. EXPOSURE Gastric bypass surgery. MAIN OUTCOMES AND MEASURES Incidence of new DR and other diabetic ocular complications. RESULTS The study population consisted of 5321 patients who had undergone GBP (3223 women [60.6%]; mean [SD] age, 49.0 [9.5] years) and 5321 matched controls (3395 women [63.8%]; mean [SD] age, 47.1 [11.5] years). Mean (SD) follow-up was 4.5 (1.6) years. The mean (SD) BMI and hemoglobin A1c concentration at baseline were 42.0 (5.7) and 7.6%(1.5%), respectively, in the GBP group and 40.9 (7.3) and 7.5%(1.5%), respectively, in the control group. The mean (SD) duration of diabetes was 6.8 (6.3) years in the GBP group and 6.4 (6.4) years in the control group. The risk for new DR was reduced in the patients who underwent GBP (hazard ratio, 0.62 [95% CI, 0.49-0.78]; P <.001). The dominant risk factors for development of DR at baseline were diabetes duration, hemoglobin A1c concentration, use of insulin, glomerular filtration rate, and BMI. CONCLUSIONS AND RELEVANCE This nationwide matched cohort study suggests that there is a reduced risk of developing new DR associated with GBP, and no evidence of an increased risk of developing DR that threatened sight or required treatment. (c) 2021 American Medical Association. All rights reserved.
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| 8. |
- Backman, Olof, et al.
(författare)
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Gastric Bypass Surgery Reduces De Novo Cases of Type 2 Diabetes to Population Levels : A Nationwide Cohort Study From Sweden
- 2019
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Ingår i: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 269:5, s. 895-902
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The aim of this study was to determine long-term changes in pharmacological treatment of type 2 diabetes after primary Roux-en-Y gastric bypass (RYGB) surgery, in patients with and without pharmacological treatment of diabetes preoperatively.SUMMARY OF BACKGROUND DATA: Several studies have shown that gastric bypass has good effect on diabetes, at least in the short-term. This study is a nationwide cohort study using Swedish registers, with basically no patients lost to follow-up during up to 7 years after surgery.METHODS: The effect of RYGB on type 2 diabetes drug treatment was evaluated in this nationwide matched cohort study. Participants were 22,047 adults with BMI ≥30 identified in the nationwide Scandinavian Surgical Obesity Registry, who underwent primary RYGB between 2007 and 2012. For each individual, up to 10 general population comparators were matched on birth year, sex, and place of residence. Prescription data were retrieved from the nationwide Swedish Prescribed Drug Register through September 2015. Incident use of pharmacological treatment was analyzed using Cox regression.RESULTS: Sixty-seven percent of patients with pharmacological treatment of type 2 diabetes before surgery were not using diabetes drugs 2 years after surgery and 61% of patients were not pharmacologically treated up to 7 years after surgery. In patients not using diabetes drugs at baseline, there were 189 new cases of pharmacological treatment of type 2 diabetes in the surgery group and 2319 in the matched general population comparators during a median follow-up of 4.6 years (incidence: 21.4 vs 27.9 per 10,000 person-years; adjusted hazard ratio 0.77, 95% confidence interval 0.67-0.89; P < 0.001).CONCLUSIONS: Gastric bypass surgery not only induces remission of pharmacological treatment of type 2 diabetes but also protects from new onset of pharmacological diabetes treatment. The effect seems to persist in most, but not all, patients over 7 years of follow-up.
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| 9. |
- Droeser, R. A., et al.
(författare)
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Hypoparathyroidism after total thyroidectomy in patients with previous gastric bypass
- 2017
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Ingår i: Langenbecks Archives of Surgery. - : Springer Science and Business Media LLC. - 1435-2443 .- 1435-2451. ; 402:2, s. 273-280
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Case reports suggest that patients with previous gastric bypass have an increased risk of severe hypocalcemia after total thyroidectomy, but there are no population-based studies. The prevalence of gastric bypass before thyroidectomy and the risk of hypocalcemia after thyroidectomy in patients with previous gastric bypass were investigated. Methods By cross-linking The Scandinavian Quality Registry for Thyroid, Parathyroid and Adrenal Surgery with the Scandinavian Obesity Surgery Registry patients operated with total thyroidectomy without concurrent or previous surgery for hyperparathyroidism were identified and grouped according to previous gastric bypass. The risk of treatment with intravenous calcium during hospital stay, and with oral calcium and vitamin D at 6 weeks and 6 months postoperatively was calculated by using multiple logistic regression in the overall cohort and in a 1:1 nested case-control analysis. Results We identified 6115 patients treated with total thyroidectomy. Out of these, 25 (0.4 %) had undergone previous gastric bypass surgery. In logistic regression, previous gastric bypass was not associated with treatment with i.v. calcium (OR 2.05, 95 % CI 0.48-8.74), or calcium and/or vitamin D at 6 weeks (1.14 (0.39-3.35), 1.31 (0.39-4.42)) or 6 months after total thyroidectomy (1.71 (0.40-7.32), 2.28 (0.53-9.75)). In the nested case-control analysis, rates of treatment for hypocalcemia were similar in patients with and without previous gastric bypass. Conclusion Previous gastric bypass surgery was infrequent in patients undergoing total thyroidectomy and was not associated with an increased risk of postoperative hypocalcemia.
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| 10. |
- Hedberg, Suzanne, et al.
(författare)
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BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy
- 2019
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Ingår i: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 84
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Tidskriftsartikel (refereegranskat)abstract
- Background: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. Method: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. Conclusions: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505. © 2019 Elsevier Inc.
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