Enteric Immune-nutrition Formula (ANOM®) for Patients Receiving Major Upper Gastrointestinal Surgery (ANOM)
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|ClinicalTrials.gov Identifier: NCT01351883|
Recruitment Status : Unknown
Verified May 2011 by National Cheng-Kung University Hospital.
Recruitment status was: Recruiting
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Upper Gastrointestinal Hemorrhage||Dietary Supplement: ANOM||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||December 2011|
No Intervention: Standard enteral nutrition supplement
regular standard enteral nutrition(SEN) was made by hospital for patient
Dietary Supplement: ANOM
the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml
- postoperative infectious complication [ Time Frame: POD 14 or discharged day ]we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM
- immunological parameters [ Time Frame: POD 14 or discharged day ]we want to compare the immunological parameters, IL-6, with stand diet group
- Free radicles -TBARS [ Time Frame: 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 parameters [ Time Frame: POD14 or discharged day ]we will compare the immunological parameters, IL-8, with the stand diet group.
- immunological parameter [ Time Frame: POD14 or discharged day ]We will compare the immunological parameter, IL-1, with the standard diet group
- immunological parameter [ Time Frame: POD14 or discharged day ]We will compare the immunological parameter, IL-10, with the standard diet group
- immunological parameters [ Time Frame: POD14 or discharged day ]We will compare the immunological parameter, TNF-a, with the standard diet group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351883
|Contact: Yan-Shen Shan, MD,PhD||88662353535 ext firstname.lastname@example.org|
|National Cheng Kung University Hospital||Recruiting|
|Tainan, Taiwan, 70428|
|Contact: Yan-Shen Shan, MD,PhD 88662353535 ext 5181 email@example.com|
|Principal Investigator: Yan-Shen Shan, MD,PhD|
|Sub-Investigator: Pin-wen Lin, MD|
|Sub-Investigator: Ai-Wen Kao, MD|
|Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Kai-Hsi Hsu, MD,PhD|
|Principal Investigator: Kai-Hsi Hsu, MD,PhD|
|Principal Investigator:||Yan-Shen Shan, MD, PhD||National Cheng-Kung University Hospital|