Preoperative Nutrition Support in Major Oncologic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- LENGTH OF HOSPITALIZATION
研究概览
简要总结
After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.
详细描述
HYPOTHESIS:
Patients receiving enteral nutrition support with immune-enhancing formulas (containing higher concentrations of arginine, glutamine and omega 3 fatty acids compared with standard polymeric formulas) during 7 days before a major oncological surgical procedure, have a lower incidence of nutritional-related postoperative complications, compared with patients without preoperative nutritional supplementation or those supplemented with standard formulas.
OBJECTIVES:
- To put in practice a routine nutritional assessment for every patient that is going to be submitted to major digestive oncologic surgery
- In these patients evaluate adherence and tolerance of enteral drinks, comparing immune-enhancing with the standard polymeric formulations, during 7 days prior to surgery
- To compare frequency of postoperative nutrition-related complications (infections, anastomotic leaks and hospital length of stay), among non-supplemented patients and those receiving preoperative immune-enhancing or standard polymeric formulas.
PATIENTS AND METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Every patient submitted for major digestive oncologic surgery in the next 8 to 10 days
- •Agrees to participate
- •Tolerates formula
排除标准
- •Emergency surgery
- •Time for surgery less than 8 days
- •Serum creatinine > 1.5 mg/dL
结局指标
主要结局
LENGTH OF HOSPITALIZATION
时间窗: 30 DAYS
次要结局
- POST OPERATIVE COMPLICATIONS(60 DAYS)
研究者
MARIA PIA DE LA MAZA
Mrs
University of Chile
