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临床试验/NCT02032199
NCT02032199已完成不适用

A Prospective Analysis of Changes in Health-Related Quality of Life Following Roux-en-Y Gastric Bypass.

René Klinkby Støving1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
试验地点
1
主要终点
36-Item Short Form Health Survey v2 (SF-36)

研究概览

简要总结

A central goal of health care is to maximize patient functioning and well-being. This has prompted measurement of health-related quality of life (HRQOL) that encompasses physical, psychological, and social functioning. While obese people have generally impaired HRQOL, people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese individuals seeking non-surgical treatment or obese individuals not seeking weight-loss treatment. HRQOL improves significantly after bariatric surgery, but often with large individual variations in outcome. As gastric bypass is an invasive procedure with irreversible influences on eating behaviour and possible serious adverse events, it is important to identify potential risk factors for a poorer long-term result. In Denmark, bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines Authority guidelines, which until 2011 were in line with international guidelines. However, in 2011 access to surgery was dramatically restricted and the annual number of operations reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The restrictions involved a tightening of the criteria for patients without manifest obesity comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the tighter criteria benefit more from surgery than patients who only met the previous criteria.

This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up over an average of 22 months. The aim was to explore whether postoperative HRQOL variations were associated with identifiable socio-demographic or clinical characteristics. In particular, whether HRQOL changes differed for patients fulfilling the current Danish criteria and patients only fulfilling the previous criteria.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for gastric bypass.

排除标准

  • Patients who did not fulfill the national criteria.

结局指标

主要结局

36-Item Short Form Health Survey v2 (SF-36)

时间窗: 24 months

次要结局

未报告次要终点

研究者

发起方
René Klinkby Støving
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

René Klinkby Støving

MD, PhD, associate professor

Odense University Hospital

研究点 (1)

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