This is nationwide registry-based randomised clinical multicenter trial in which patients will be randomised to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary endpoint are weight control over 5 years and the amount of severe adverse events. Additionally the investigators have predefined a number of secondary endpoints, and the trial has a sufficient number of patients to allow comparisons across subgroups.
Follow-up of the patients will use the routines respectively for regular follow-up on the Scandinavian Obesity Surgery Registry (SOReg) after 6v, 1 year, 2 years, and after 5 years. In order to evaluate if SG has advantages compared to the previous standard, the investigators want to examine whether SG operations are equivalent (non-inferiority) for weight loss and weight stability five years after surgery in comparison to RYGB, and if SG is associated with fewer long-term complications (superiority). The primary outcome measure emanates from assessment of long term weight management and the frequency of serious complications. The unforeseen global Covid-19 pandemic resulted in that almost all elective benign surgery in Scandinavia was cancelled from March 2020. Thus, the pandemic had severe consequences on the recruitment to the BEST trial during 2020-2021. During autumn of 2021 the BEST steering committee decided to perform an additional analysis of the power for primary endpoints. Additional information (Courcoulas et al, JAMA Surg 2020 March; Howard et al, JAMA Surg 2021 Dec) revealed that the risk of any of the predefined substantial adverse events after bariatric surgery is higher than previously anticipated in the revised power calculation, i.e. \>25% instead of 13%. These figures were confirmed in an analysis of real-world data from the bariatric national quality register SOReg in Sweden which registered all patients undergoing sleeve or bypass in Sweden since 2007. An independent statistician performed the analysis based on information above, but also on 2-year data in BEST. In conclusion, it was stated: Two post hoc power analyses were conducted based on the data from February 2022: 1. Weight reduction. In the protocol the following is stated "This sample size will also have \>95% power to evaluate non-inferiority of 5% weight loss difference over 5 years between the two groups, assuming 15 kg standard deviation in weight loss over follow-up with two-sided 2.5% significance level.". The post hoc power calculation is based on the two-year follow up data where an average weight loss for all patients (both groups, N=1031) of 29.3 kg was attained with a Sd=21.6. Given a loss to follow up of 20% from 2 year follow up to the 5-year follow up the sample size is assumed to be (1031\*0.80)/2=413 patients per group. With a non-inferiority level of 5 kg weight loss the power is found to be 90% if n=393 per group, and 95% if n=486 per group (https://www.sealedenvelope.com/power/continuous-noninferior/). 2. Substantial adverse events. This post hoc power calculation is for a superiority test where the rate is assumed to be 25% for the gastric bypass at 5 years and sleeve would have a 35% lower level, i e 25%\*0.65=16.25%. Given a sample of n=413 per group the post hoc power will then be 87.5%. Taking information above into account and in the interest of not prolonging inclusion period unnecessarily the trial steering committee took a decision to stop inclusion in BEST during spring 2022 (final date 31st of March). At termination of inclusion the number of participants that had been included and operated in BEST were 1752. The trial Data Safety and Monitoring Committee reviewed and supported the decision before termination of recruitment to the BEST trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,752
Type of surgery: gastric bypass
Typ of surgery: sleeve gastrectomy
Sentralsykehuset Vestfold
Tønsberg, Norway
Falu Hospital
Falun, Sweden
Weight loss
Non-inferiority for SG is defined as \< 5% weight difference
Time frame: 5 years
Serious adverse events
Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB
Time frame: 5 years
Adverse events
General description of patterns of all adverse events
Time frame: 1, 2, 5 and 10 years
Weight loss
Between baseline and 1 and 2 years
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients with arterial cardiovascular events
Composite of myocardial infarction+ stroke+ other occlusive arterial condition
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients with venous event
Composite of Deep vein thrombosis+ Pulmonary emboli+ other venous event
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients with diabetes requiring drug treatment
Development of diabetes measured as numbers of patients having a diabetes diagnosis and oral medication and injection therapy
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients with a psychiatric morbidity
Number of patients with a psychiatric morbidity
Time frame: Baseline, 1, 2, 5 and 10 years
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Gävle Hospital
Gävle, Sweden
Östra Hospital
Gothenburg, Sweden
Kalmar County Hospital
Kalmar, Sweden
Lindesbergs Hospital
Lindesberg, Sweden
Linköping University
Linköping, Sweden
Ljungby Hospital
Ljungby, Sweden
Lycksele Hospital
Lycksele, Sweden
Mora Hospital
Mora, Sweden
...and 11 more locations
Number of patients with hypertension treatment
Number of patients with hypertension treatment (any type of Medical treatment)
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients diagnosed with a malignancy
Number of patients diagnosed with a malignancy
Time frame: Baseline, 1, 2, 5 and 10 years
Number of patients with dyslipidemia treatment
Number of patients with diagnosis of dyslipidemia and on oral lipid lowering treatment
Time frame: Baseline, 1, 2, 5 and 10 years
Weight in men and women
Analyses of the primary outcome weight in men and women
Time frame: Baseline, 1, 2, 5 and 10 years
serious adverse events in men and women
Analyses of the primary outcome serious adverse events in men and women
Time frame: Baseline, 1, 2, 5 and 10 years
Weight in patients with BMI >43 vs <43 kg/m2.
Analyses of the primary outcome weight in patients with BMI \>43 vs \<43 kg/m2.
Time frame: Baseline, 1, 2, 5 and 10 years
Serious adverse events in patients with BMI >43 vs <43 kg/m2
Analyses of the primary outcome serious adverse events in patients with BMI \>43 vs \<43 kg/m2.
Time frame: Baseline, 1, 2, 5 and 10 years
Weight in patients aged 18-25 y, 25-50 y, or >50 y
Analyses of the primary outcome weight in patients aged 18-25 y, 25-50 y, or \>50 y
Time frame: Baseline, 1, 2, 5 and 10 years
Serious adverse events in patients aged 18-25 y, 25-50 y, or >50 y
Analyses of the primary outcome serious adverse events in patients aged 18-25 y, 25-50 y, or \>50 y
Time frame: Baseline, 1, 2, 5 and 10 years
Mineral nutritional status
Serum concentrations of iron depots, zinc, magnesium, selenium and copper
Time frame: Baseline, 1, 2, 5 and 10 years
Vitamin nutritional status
Serum concentrations of vitamins (Vitamin B12, Vitamin D, Vitamin A, thiamin)
Time frame: Baseline, 1, 2, 5 and 10 years
Serum concentrations of albumin
Serum concentrations of Albumin
Time frame: Baseline, 1, 2, 5 and 10 years
Changes in quality of Life assessed with EQ-5D
Assessed with EQ-5D
Time frame: Baseline, 1, 2, 5 and 10 years
Changes in quality of Life assessed with Obesity Problems (OP)
Assessed with Obesity Problems (OP)
Time frame: Baseline, 1, 2, 5 and 10 years
Changes in quality of Life assessed with Short Form-36
Assessed with SF-36
Time frame: Baseline, 1, 2, 5 and 10 years
Alcohol consumption
Assessed by AUDIT
Time frame: 1, 2, 5 and 10 years
Gastro-esophageal reflux disease
Gastro-esophageal reflux disease is defined as present/ not present in at least one of following modalities: Questionnaire DeMeester score, 24h pH manometry and/or gastroscopy
Time frame: 1, 2, 5 and 10 years
Fracture incidence
From clinical data and national registry
Time frame: 2, 5 and 10 years
Bone density and body composition
Dual energy X-ray Absorptiometry (DEXA) in at least a subgroup of 500+500
Time frame: 10 years
Mortality and cause of death
National Cause of Death registry
Time frame: 5, 10, 20 and 30 years
Health care consumption, In hospital registry
Data from In hospital registry (Days in hospital)
Time frame: 5, 10, 20 and 30 years
Health care consumption,
Data from Outpatient registry ( number of visits)
Time frame: 5, 10, 20 and 30 years
Health care consumption
National drug registry (type of drug)
Time frame: 5, 10, 20 and 30 years
Development of co-morbidities from national registry data
National stroke registry, National Cardiac registry, National Diabetes Registry, Cancer registry
Time frame: 5, 10, 20, 30 years
Formal cost effective analysis
Cost per quality-adjusted life-year and life-year)
Time frame: 5, 10 and 20 years
Dietary intake
Questionnaire regarding food intake (E14x)
Time frame: 1 and 10 years
Eating patterns
Three Factor Eating Questionnaire (TFEQ)
Time frame: 1 and 10 years
Gastro-intestinal side effects
Questionnaire: Gastro-intestinal Symptom Rating Score (GSRS)
Time frame: 1 and 10 years
Dumping symptoms
Questionnaire: Dumping Symptom Rating Score (DSRS)
Time frame: 1 and 10 years
Adverse events
Clinical data combined with national registry data
Time frame: 30 days postop, 1, 2, 5 and 10 years
Peri-operative outcome, Complications
Complications; Surgical (minor/major) and medical
Time frame: Up to 30 days postop
Peri-operative outcome, surgical time
surgical time (min)
Time frame: Up to 30 days postop
Peri-operative outcome, sick leave
sick leave (days)
Time frame: Up to 30 days postop
Peri-operative outcome, length of stay
length of stay (days)
Time frame: Up to 30 days postop