Chronic Upper Gastrointestinal Hemorrhage
Conditions
Keywords
immunomodulating diet, postoperative infection
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTANOM
the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ranged from 18 to 80 years old 2. 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. 3. Patient is able to understand the requirements of the study and signs the Informed Consent Form.
Exclusion criteria
1. Patient with severe malnutrition condition, albumin \< 2.6mg/ml 2. Patient with severe pulmonary, cardiovascular, renal or hepatic disease 3. Patient with immunosuppressive therapy or immunological disease recently 4. Patient with on-going infection with any condition 5. Patient with emergency operation 6. Patient with widespread metastatic disease before surgery 7. Patient with bowel obstruction disease 8. Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative infectious complication | POD 14 or discharged day | we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunological parameters | POD 14 or discharged day | we want to compare the immunological parameters, IL-6, with stand diet group |
| Free radicles -TBARS | POD 14 or discharged day | we will esitimate the difference blood level of free radicles by ELISA and compared with that in the standard diet group |
| immunological parameter | POD14 or discharged day | We will compare the immunological parameter, IL-1, with the standard diet group |
Countries
Taiwan
Contacts
Primary ContactYan-Shen Shan, MD,PhD
Outcome results
None listed