Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- postoperative infectious complication
研究概览
简要总结
Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery.
(ANOM®)immunonutrition product name
详细描述
Background: Perioperative usage of immunonutrition can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. The aim of this study was to elucidate the effect of immunomodulating diets, ANOM®, on surgical outcome in elective major upper gastrointestinal tract operations.
Material and Methods
Design: Prospective, randomized, controlled trial. Participants: Seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagus、stomach、pancreas or duodenum, Interventions: Patients will be divided randomly into two groups to receive ANOM® or standard diet. Before surgery, 800ml ANOM® or standard diet (SEN) will be given for 5 days by mouth. After operation, 5% Distill water (D5W) combined with ANOM® or standard diet since the 2nd post-operation day (POD2) until day 14 (POD14) or until discharged day by enteric route using nasogastric tube(NG) tube or jejunostomy. Postoperative parenteral nutrition will be given to maintain adequate nutrition.
Clinical Assessment: The preoperative and postoperative immunological parameters, infection complications, and hospital stay will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged from 18 to 80 years old
- •Patients with upper gastrointestinal diseases, and was planning to receive elective major upper gastrointestinal tract surgery, such as subtotal gastrectomy, proximal gastrectomy, total gastrectomy, esophagectomy, pancreatectomy, pancreaticoduodenectomy, duodenectomy, etc.
- •Patient is able to understand the requirements of the study and signs the Informed Consent Form.
排除标准
- •Patient with severe malnutrition condition, albumin < 2.6mg/ml
- •Patient with severe pulmonary, cardiovascular, renal or hepatic disease
- •Patient with immunosuppressive therapy or immunological disease recently
- •Patient with on-going infection with any condition
- •Patient with emergency operation
- •Patient with widespread metastatic disease before surgery
- •Patient with bowel obstruction disease
- •Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
结局指标
主要结局
postoperative infectious complication
时间窗: POD 14 or discharged day
we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM
次要结局
- Free radicles -TBARS(POD 14 or discharged day)
- immunological parameters(POD14 or discharged day)
- immunological parameter(POD14 or discharged day)