Impact of Immunomodulating Oral Nutrition on Surgical Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Surgical complications
研究概览
简要总结
The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.
详细描述
The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (IM) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by European Society for Clinical Nutrition and Metabolism (ESPEN) in 2006 recommended to use IM for 7-14 days preoperatively in all patients undergoing major surgeries. Some authors questioned IM by showing no benefit of IM over standard enteral nutrition. Other authors observed similar results.The debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. One year later, ESPEN changed its surgical recommendations and advised to use IM preoperatively in malnourished and perioperatively in well-nourished patients. American recommendations remained unchanged and, according to them, it is advised to use IM preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option.
To address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) < 18),
- •good general status (Karnofsky Performance Index > 80,
- •Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
- •no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.),
- •no history of known allergies or drug intolerance to analyzed substances.
排除标准
- •Patients malnourished or with metastatic disease,
- •pregnant,
- •in poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1),
- •recent history of severe heart, lung, kidney or liver failure,
- •history of allergies or drug intolerance
研究组 & 干预措施
Immunonutrition
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
干预措施: Immunonutrition (Dietary Supplement)
High-protein diet
Oral nutrition with high-protein content
干预措施: High-protein (Dietary Supplement)
Standard nutrition
Oral nutrition with standard components
干预措施: Standard ONS (Dietary Supplement)
结局指标
主要结局
Surgical complications
时间窗: 6 months
Number and type of surgical complications
Infectious complications
时间窗: 6 months
Number and type of infectious complications
次要结局
- Length of stay(6 months)
研究者
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital
