ISEEN: Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition

• Sponsor: Jinling Hospital, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01778166
• Collaborator: National Natural Science Foundation of China (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Malignant	Drug: Immuno-enhanced; Drug: Standard early enteral nutrition	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard early enteral nutrition There would be 100 patients in this group	Drug: Standard early enteral nutrition; 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	Drug: Immuno-enhanced; 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

Outcome Measures

Primary Outcome Measures

1. Time to tolerate IEEN/SEEN [30 days after operation]

Secondary Outcome Measures

1. Overall morbidity rate of IEEN/SEEN [60 days after operation]

2. Mortality rate of IEEN/SEEN after operation [60 days after operation]

3. Energy metabolism [10 days after operation]

4. Time to the first postoperative adjuvant chemotherapy [30 days after operation]

5. Nutritional status in postoperative day1and 7 of IEEN/SEEN [7 days after operation]

6. Immune function in postoperative day 1 and 7 [7 days after operation]

7. Postoperative hospital stay length [60 days after operation]

8. Rehospitalization rate [30 days after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinling Hospital	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

• Jinling Hospital, China
• National Natural Science Foundation of China

Investigators

• Principal Investigator: Danhua Yao, MD/PhD, Nanjing University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Danhua Yao, Senior Resident, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT01778166
• Other Study ID Numbers: ISEEN001; ISEEN
• First Posted: Jan 29, 2013
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Danhua Yao, Senior Resident, Jinling Hospital, China: Early enteral nutrition; Laparoscopic gastrointestinal surgery; Immuno-enhanced nutrition

Study Results

No Results Posted as of Jan 31, 2013