Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Postoperative pain
研究概览
简要总结
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
详细描述
Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >40 Kg/m2
- •BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
排除标准
- •gastroesophageal reflux
- •patients with uncontrolled psychiatric disorders
- •active infections or malignancies
- •other concomitant pathology considered as a contraindication for bariatric surgery
研究组 & 干预措施
regular diet
The patients receive regular diet of 900 Kcal/day during 15 days before surgery
干预措施: Regular diet (Dietary Supplement)
high protein formula
The patients receive high protein formula during 15 days before surgery
干预措施: High protein formula (Dietary Supplement)
Immunonutrition
The patients receive Immunonutrition during 15 days before surgery
干预措施: Immunonutrition (Dietary Supplement)
结局指标
主要结局
Postoperative pain
时间窗: 24 hours after surgery
次要结局
- C reactive protein(24 hours after surgery)
研究者
Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Hospital General Universitario Elche