Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Perception of General Health
研究概览
简要总结
The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied.
详细描述
The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m^2 and 34.5 kg/m^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery.
- •Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study.
排除标准
- •Patients who are pregnant.
- •Patients with BMI below 30 kg/m
- •Patients with BMI above 34.5 kg/m
- •Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease.
- •Patients who are not medically cleared to undergo weight loss surgery.
结局指标
主要结局
Change in Perception of General Health
时间窗: 0, 1, 3, 6, 12 months
A survey will be administered to determine changes in one's self-assessed general health.
Change in Perception of Body Image
时间窗: 0, 1, 3, 6, 12 months
Surveys will be administered to determine changes in one's self-assessed body image.
Change in Perception of Quality of Life
时间窗: 0, 1, 3, 6, 12 months
Surveys will be administered to determine changes in one's self-assessed quality of life.
次要结局
未报告次要终点