苏格兰重度肥胖成人减肥手术的临床效果和不良事件:SCOTS 观察性队列研究。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Ruth M Mackenzie, Abdulmajid Ali, Duff Bruce, Julie Bruce, Ian Ford, Nicola Greenlaw, Eleanor Grieve, Mike Lean, Robert S Lindsay, Joanne O'Donnell, Naveed Sattar, Sally Stewart, Jennifer Logue
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引用次数: 0

摘要

背景:减肥手术是世界范围内治疗严重肥胖症及相关并发症的常见手术:减肥手术是世界范围内治疗严重肥胖症及相关并发症的常见手术,但在英国,缺乏中期安全性和有效性的证据:目的:确定不同减肥手术的临床效果和不良事件、对生活质量的影响以及对合并症的影响:设计:前瞻性观察队列研究:地点:英国苏格兰国民健康服务二级医疗机构和私人诊所:接受首次减肥手术的成年人(年龄大于 16 岁):体重变化、住院时间、再入院率和再手术率、死亡率、糖尿病结果(HbA1c、药物)、生活质量、焦虑、抑郁:患者报告的结果测量、医院记录、国家电子健康记录(苏格兰01年发病记录、苏格兰糖尿病护理信息、苏格兰国家记录、处方信息系统):2013年12月至2017年2月期间,共接触了548名符合条件的患者,其中445人参加了研究。其中 335 人接受了减肥手术,1 人退出研究。平均年龄为 46.0 (9.2) 岁,74.7% 为女性,体重指数中位数为 46.4 (42.4; 52.0) kg/m2。128名参与者3年后的体重:与手术前相比,平均变化率为-19.0%(±14.1);与术前体重管理计划开始时相比,平均变化率为-24.2%(±12.8)。139名参与者(41.4%)在术后35个月内再次入院,18名参与者(占手术组群的5.4%)进行了再次手术或被认为与减肥手术胃肠道并发症或翻修有关的手术。少于五名参与者(p = 0.001)mmol/mol,65.5%的人无需服用糖尿病药物(p p 局限性:由于苏格兰的减肥手术数量较少,在达到预定的2000名参与者之前就停止了招募,随访时间也从10年缩短为3年:减肥手术是一种安全有效的肥胖症治疗方法。结论:减肥手术是治疗肥胖症的一种安全有效的方法。与国际比较者相比,英国苏格兰的患者似乎年龄更大、体重更高,这可能是由于实施的手术数量较少:未来工作:需要开展干预研究,以确定最佳的术前和术后路径,最大限度地提高安全性和成本效益:本研究已注册为ISRCTN47072588:该奖项由美国国家健康与护理研究所(NIHR)健康技术评估项目资助(NIHR奖项编号:10/42/02),全文发表于《健康技术评估》(Health Technology Assessment)第28卷第7期。更多奖项信息,请参阅 NIHR Funding and Awards 网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical outcomes and adverse events of bariatric surgery in adults with severe obesity in Scotland: the SCOTS observational cohort study.

Background: Bariatric surgery is a common procedure worldwide for the treatment of severe obesity and associated comorbid conditions but there is a lack of evidence as to medium-term safety and effectiveness outcomes in a United Kingdom setting.

Objective: To establish the clinical outcomes and adverse events of different bariatric surgical procedures, their impact on quality of life and the effect on comorbidities.

Design: Prospective observational cohort study.

Setting: National Health Service secondary care and private practice in Scotland, United Kingdom.

Participants: Adults (age >16 years) undergoing their first bariatric surgery procedure.

Main outcome measures: Change in weight, hospital length of stay, readmission and reoperation rate, mortality, diabetes outcomes (HbA1c, medications), quality of life, anxiety, depression.

Data sources: Patient-reported outcome measures, hospital records, national electronic health records (Scottish Morbidity Record 01, Scottish Care Information Diabetes, National Records Scotland, Prescription Information System).

Results: Between December 2013 and February 2017, 548 eligible patients were approached and 445 participants were enrolled in the study. Of those, 335 had bariatric surgery and 1 withdrew from the study. Mean age was 46.0 (9.2) years, 74.7% were female and the median body mass index was 46.4 (42.4; 52.0) kg/m2. Weight was available for 128 participants at 3 years: mean change was -19.0% (±14.1) from the operation and -24.2% (±12.8) from the start of the preoperative weight-management programme. One hundred and thirty-nine (41.4%) participants were readmitted to hospital in the same or subsequent 35 months post surgery, 18 (5.4% of the operated cohort) had a reoperation or procedure considered to be related to bariatric surgery gastrointestinal complications or revisions. Fewer than five participants (<2%) died during follow-up. HbA1c was available for 93/182 and diabetes medications for 139/182 participants who had type 2 diabetes prior to surgery; HbA1c mean change was -5.72 (±16.71) (p = 0.001) mmol/mol and 65.5% required no diabetes medications (p < 0.001) at 3 years post surgery. Physical quality of life, available for 101/335 participants, improved in the 3 years post surgery, mean change in Rand 12-item Short Form Survey physical component score 8.32 (±8.95) (p < 0.001); however, there was no change in the prevalence of anxiety or depression.

Limitations: Due to low numbers of bariatric surgery procedures in Scotland, recruitment was stopped before achieving the intended 2000 participants and follow-up was reduced from 10 years to 3 years.

Conclusions: Bariatric surgery is a safe and effective treatment for obesity. Patients in Scotland, UK, appear to be older and have higher body mass than international comparators, which may be due to the small number of procedures performed.

Future work: Intervention studies are required to identify the optimal pre- and post surgery pathway to maximise safety and cost-effectiveness.

Study registration: This study is registered as ISRCTN47072588.

Funding details: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 10/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 7. See the NIHR Funding and Awards website for further award information.

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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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