Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.
详细描述
In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for bariatric surgery
排除标准
- 未提供
研究组 & 干预措施
Very Low Calorie Diet (VLCD)
VLCD
干预措施: VLCD (Dietary Supplement)
Standard care
Standard care
干预措施: Standard care (Dietary Supplement)
结局指标
主要结局
Weight loss
时间窗: 8 weeks
次要结局
- Presence of eating disorders(At baseline)
- Patient quality of life measured using the Short Form-12 (SF-12) questionnaire(8 weeks and 1 year)
- Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose(30 days after surgery)
- Use of health care services assessed by a medical chart review(30 days after surgery)
- Severity of complications assessed by a medical chart review.(30 days after surgery)