Chronic Upper Gastrointestinal Hemorrhage Clinical Trial
Official title:
Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention