Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01351883
Status:
UNKNOWN
Last Update Posted:
2011-05-11
First Post:
2011-01-31
Brief Title:
Enteric Immune-nutrition Formula ANOM for Patients Receiving Major Upper Gastrointestinal Surgery
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Peri-operative Usage of Enteric Immune-nutrition Formula ANOM Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANOM
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
ANOMimmunonutrition product name
ANOMimmunonutrition 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 eesophagusstomachpancreas 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 tubeNG 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
Material and Methods
Design Prospective randomized controlled trial Participants Seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagusstomachpancreas 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 tubeNG 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None