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临床试验/NCT05069402
NCT05069402已完成不适用

Impact of Immunomodulating Oral Nutrition on Surgical Complications

Stanley Dudrick's Memorial Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

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

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

Experimental

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

干预措施: Immunonutrition (Dietary Supplement)

High-protein diet

Active Comparator

Oral nutrition with high-protein content

干预措施: High-protein (Dietary Supplement)

Standard nutrition

Active Comparator

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

发起方
Stanley Dudrick's Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanislaw Klek

Head of the Unit

Stanley Dudrick's Memorial Hospital

研究点 (2)

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