- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778166
Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition (ISEEN)
Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.
The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Danhua Yao, MD/PhD
- Phone Number: 8602580860961
- Email: yaodh87@gmail.com
Study Contact Backup
- Name: Yousheng Li, MD/PhD
- Phone Number: 8602580860137
- Email: liys@medmail.com.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- Jinling Hospital
-
Contact:
- Danhua Yao, MD/PhD
- Phone Number: 8602580860037
-
Principal Investigator:
- Danhua Yao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resectable gastric cancer by laparoscope
- Resectable colorectal cancer laparoscope
- Resectable gastrointestinal interstitialoma by laparoscope
Exclusion Criteria:
- Locally unresectable tumor
- Metastatic tumor
- Preoperative total parenteral or enteral nutrition
- Lack of the patient's consent for the trial participation
- Previous gastrointestinal resection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard early enteral nutrition
There would be 100 patients in this group
|
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
|
Experimental: Immuno-enhanced early enteral nutrition
There would 100 patients in this group
|
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to tolerate IEEN/SEEN
Time Frame: 30 days after operation
|
30 days after operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Energy metabolism
Time Frame: 10 days after operation
|
10 days after operation
|
Postoperative hospital stay length
Time Frame: 60 days after operation
|
60 days after operation
|
Rehospitalization rate
Time Frame: 30 days after discharge
|
30 days after discharge
|
Overall morbidity rate of IEEN/SEEN
Time Frame: 60 days after operation
|
60 days after operation
|
Mortality rate of IEEN/SEEN after operation
Time Frame: 60 days after operation
|
60 days after operation
|
Time to the first postoperative adjuvant chemotherapy
Time Frame: 30 days after operation
|
30 days after operation
|
Nutritional status in postoperative day1and 7 of IEEN/SEEN
Time Frame: 7 days after operation
|
7 days after operation
|
Immune function in postoperative day 1 and 7
Time Frame: 7 days after operation
|
7 days after operation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Danhua Yao, MD/PhD, Nanjing University
Publications and helpful links
General Publications
- Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.
- Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.
- Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ISEEN001
- ISEEN (Registry Identifier: ISEEN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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