Bypass Equipoise Sleeve Trial (BEST); A Randomised Controlled Multicenter Trial Comparing Gastric Bypass and Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,752
- 试验地点
- 30
- 主要终点
- Weight loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 35-50 kg/m2
- •Ability to understand and decide on the merits of the study participation
- •Accepted for bariatric surgery
- •Must understand the information, and be able to make a decisions about participation in the study
排除标准
- •Previous bariatric surgery, anti reflux surgery or other gastric surgery
- •Moderate to severe reflux disease, Barretts oesophagus or known hiatus hernia >4 cm
- •Unstable mental illness or other known contraindication to bariatric surgery.
- •Planned significant surgery at the same time
- •Inflammatory bowel disease
- •ongoing drug or substance abuse
- •not appropriate to randomise the patient, according to surgeon
结局指标
主要结局
Weight loss
时间窗: 5 years
Non-inferiority for SG is defined as \< 5% weight difference
Serious adverse events
时间窗: 5 years
Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB
次要结局
- Health care consumption(5, 10, 20 and 30 years)
- Number of patients with arterial cardiovascular events(Baseline, 1, 2, 5 and 10 years)
- Number of patients with a psychiatric morbidity(Baseline, 1, 2, 5 and 10 years)
- Weight in men and women(Baseline, 1, 2, 5 and 10 years)
- Weight in patients with BMI >43 vs <43 kg/m2.(Baseline, 1, 2, 5 and 10 years)
- Weight in patients aged 18-25 y, 25-50 y, or >50 y(Baseline, 1, 2, 5 and 10 years)
- Serious adverse events in patients aged 18-25 y, 25-50 y, or >50 y(Baseline, 1, 2, 5 and 10 years)
- Changes in quality of Life assessed with EQ-5D(Baseline, 1, 2, 5 and 10 years)
- Changes in quality of Life assessed with Obesity Problems (OP)(Baseline, 1, 2, 5 and 10 years)
- Number of patients diagnosed with a malignancy(Baseline, 1, 2, 5 and 10 years)
- Development of co-morbidities from national registry data(5, 10, 20, 30 years)
- Formal cost effective analysis(5, 10 and 20 years)
- Number of patients with venous event(Baseline, 1, 2, 5 and 10 years)
- Number of patients with dyslipidemia treatment(Baseline, 1, 2, 5 and 10 years)
- Mineral nutritional status(Baseline, 1, 2, 5 and 10 years)
- Health care consumption,(5, 10, 20 and 30 years)
- Adverse events(30 days postop, 1, 2, 5 and 10 years)
- Number of patients with diabetes requiring drug treatment(Baseline, 1, 2, 5 and 10 years)
- Number of patients with hypertension treatment(Baseline, 1, 2, 5 and 10 years)
- serious adverse events in men and women(Baseline, 1, 2, 5 and 10 years)
- Serious adverse events in patients with BMI >43 vs <43 kg/m2(Baseline, 1, 2, 5 and 10 years)
- Vitamin nutritional status(Baseline, 1, 2, 5 and 10 years)
- Alcohol consumption(1, 2, 5 and 10 years)
- Mortality and cause of death(5, 10, 20 and 30 years)
- Eating patterns(1 and 10 years)
- Peri-operative outcome, sick leave(Up to 30 days postop)
- Weight loss(Baseline, 1, 2, 5 and 10 years)
- Serum concentrations of albumin(Baseline, 1, 2, 5 and 10 years)
- Changes in quality of Life assessed with Short Form-36(Baseline, 1, 2, 5 and 10 years)
- Bone density and body composition(10 years)
- Dietary intake(1 and 10 years)
- Gastro-intestinal side effects(1 and 10 years)
- Dumping symptoms(1 and 10 years)
- Gastro-esophageal reflux disease(1, 2, 5 and 10 years)
- Fracture incidence(2, 5 and 10 years)
- Health care consumption, In hospital registry(5, 10, 20 and 30 years)
- Peri-operative outcome, length of stay(Up to 30 days postop)
- Peri-operative outcome, Complications(Up to 30 days postop)
- Peri-operative outcome, surgical time(Up to 30 days postop)