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临床试验/NCT01032512
NCT01032512撤回3 期

Preoperative Nutrition Support in Major Oncologic Surgery

University of Chile1 个研究点 分布在 1 个国家开始时间: 2009年12月1日最近更新:
适应症

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

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

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

MARIA PIA DE LA MAZA

Mrs

University of Chile

研究点 (1)

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