Effect of 3 Day Pre-operative Immunonutrition Regimen on Clinical Outcome in Well-nourished Patients With Gastrointestinal Cancer Undergoing Surgery , a Randomised Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 107
- 试验地点
- 11
- 主要终点
- Rate of post-operative complications
研究概览
简要总结
Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. Surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. It has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.
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 (Participant, Investigator, Outcomes Assessor)
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
- •Patients with GI cancer (stomach, pancreas, small and large bowel and rectum) histologically proven
- •Well nourished patients as defined by a total score of <3 on the nutritional screening tool NRS-2002 (46) (Appendix III)
- •Patients who are >= 18 years of age;
- •Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study;
- •Patients who have an ECOG performance status of 0, 1 or 2 (Appendix II).
- •Patients able to orally consume 750 mL or more of liquid a day prior to surgery
排除标准
- •Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
- •Patients who are pregnant;
- •Patients with cardiac failure as defined by the Goldman classification class>3
- •Patients with respiratory failure (FEV<0.8l/sec)
- •Patients with renal failure (Cr >= 3mg/dl or dialysis patients)
- •Patients with hepatic dysfunction (Child >A)
- •Patients suffering from an intestinal obstruction or ileum
- •Patients with an Hb level of <=8 g/dL experiencing gastrointestinal hemorrhaging
- •Patients with HIV, HCV, HBV
- •Patients requiring immunosuppression treatments
- •Patients undergoing emergency surgery
- •Other patients determined by a study investigator to be inappropriate for enrolment in this study
研究组 & 干预措施
Nutritional product
Oral nutritional supplement containing immuno nutrients
干预措施: Immunonutrition (Dietary Supplement)
Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
干预措施: Immunonutrition (Dietary Supplement)
结局指标
主要结局
Rate of post-operative complications
时间窗: On the day of discharge from hospital
次要结局
- Nutritional status evaluation(On the day of discharge from hospital)
- Length of hospital stay(On the day of discharge from hospital)
- Rate of post-operative infectious complications(On the day of discharge from hospital)
- Incidence of non-infectious complications(On the day of discharge from hospital)