BACKGROUND There is still a lack of knowledge on long-term effects of surgical and non-surgical weight-lowering treatments. BASUN is a prospective study with 10 years of follow-up that will observe the effects and consequences of surgical and medical treatment of obesity. The aims are to cover areas where data on long-term outcomes are lacking, e.g., nutritional deficiencies, substance abuse, psychiatric health, as well as patient-reported outcomes. METHODS BASUN is a cohort study that recruited study persons with obesity (BMI ≥ 35 kg/m2) referred to the Regional Obesity Centre of Region Västra Götaland. The interventions were Roux-en-Y gastric bypass (RYGB) or Sleeve gastrectomy (SG), or 12 months of structured, multi-professional medical treatment (MT), including very low energy diet, followed by diet and pharmaceutical treatment. The study is not randomized, but based on patients preferences and multidisciplinary assessments. The study persons are examined at baseline, 2, 5, and 10 years with blood tests, measurements and questionnaires. The recruitment period lasted from May 2015 to November 2017. RESULTS One thousand one hundred twenty-seven patients were included (74% female). Three hundred eighty-two patients were accepted for medical treatment, 589 for surgical treatment (388 RYGB and 201 SG) and 156 patients left the study without treatment, leaving a final study population of 971 patients. There were slight differences between the treatment groups with regards to age and BMI. Pharmaceutical treatments, level of education, smoking and marital status were not significantly different between the groups. CONCLUSION This study will follow 971 obese subjects in clinical practice treated with the best surgical or medical methods currently available. It has the potential to evaluate outcomes usually not reported in short-term studies, and to assist in identifying factors that are of importance for the choices of treatment. The main limitations are non-randomization and differences in baseline characteristics. The large number of participants and the length of the prospective follow-up are major strengths of the study. BASUN is designed to identify both early and late benefits and adverse events of treatment of obesity. TRIAL REGISTRATION This trial was prospectively registered on March 03, 2015; NCT03152617.

中文翻译：

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BAriatic 手术替代和营养研究 (BASUN) 的设计和基线数据：一项为期 10 年的前瞻性队列研究。

背景对于手术和非手术减肥治疗的长期效果仍然缺乏了解。BASUN 是一项为期 10 年的前瞻性研究，将观察手术和药物治疗肥胖的效果和后果。目的是涵盖缺乏长期结果数据的领域，例如营养缺乏、药物滥用、精神健康以及患者报告的结果。方法 BASUN 是一项队列研究，招募了西约塔兰地区肥胖中心的肥胖研究人员（BMI ≥ 35 kg/m2）。干预措施是 Roux-en-Y 胃绕道手术 (RYGB) 或袖状胃切除术 (SG)，或为期 12 个月的结构化、多专业医疗 (MT)，包括极低能量饮食，然后进行饮食和药物治疗。该研究不是随机的，而是基于患者的偏好和多学科评估。研究人员在基线、2 年、5 年和 10 年时接受血液检查、测量和问卷调查。招募期从 2015 年 5 月持续到 2017 年 11 月。 结果 纳入了 1127 名患者（74% 为女性）。382 名患者接受内科治疗，589 名患者接受手术治疗（388 名 RYGB 和 201 名 SG），156 名患者未经治疗退出研究，最终研究人群为 971 名患者。治疗组之间在年龄和体重指数方面存在轻微差异。药物治疗、教育水平、吸烟和婚姻状况在各组之间没有显着差异。结论 本研究将跟踪 971 名临床实践中接受目前最佳手术或医疗方法治疗的肥胖受试者。它有可能评估短期研究中通常未报告的结果，并帮助确定对治疗选择重要的因素。主要限制是非随机化和基线特征的差异。参与者数量大和前瞻性随访时间长是该研究的主要优势。BASUN 旨在识别肥胖治疗的早期和晚期益处以及不良事件。试验注册 该试验于2015年3月3日前瞻性注册；NCT03152617。