The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Operative time of the RYGB procedure
研究概览
简要总结
Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting.
This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.
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
- None
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
- •Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
- •Able to prepare the meal replacements at home
排除标准
- •Undergoing another bariatric procedure than primary RYGB.
- •Diabetes Mellitus
- •Contraindication for the usage of Modifast meal replacements:
- •Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds)
- •Kidney failure (GFR < 90 ml/min/1.73m2), liver failure or cardiac insufficiency
- •A heart attack (myocardial infarct) in the past twelve months
- •Hypokalaemia: serum potassium level <3.4 mmol/l
- •Phenylketonuria & Porphyria
研究组 & 干预措施
Intervention group
Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods.
For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres.
For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres.
干预措施: 14-day Low Calorie Diet (Other)
Control group
Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery.
结局指标
主要结局
Operative time of the RYGB procedure
时间窗: surgery
Duration of the surgical procedure, retrieved from the electronic medical record
次要结局
- Appearance of the patient's liver(surgery)
- Ease of the RYGB procedure(surgery)
- Post-operative weight loss(4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery)