Clinical trial NCT01778166: Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition
Official title: Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastrointestinal Malignant
Keywords: Early enteral nutrition
Laparoscopic gastrointestinal surgery
Immuno-enhanced nutrition
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to tolerate IEEN/SEEN
timeFrame: 30 days after operation
Secondary outcomes:
measure: Overall morbidity rate of IEEN/SEEN
timeFrame: 60 days after operation
measure: Mortality rate of IEEN/SEEN after operation
timeFrame: 60 days after operation
measure: Energy metabolism
timeFrame: 10 days after operation
measure: Time to the first postoperative adjuvant chemotherapy
timeFrame: 30 days after operation
measure: Nutritional status in postoperative day1and 7 of IEEN/SEEN
timeFrame: 7 days after operation
measure: Immune function in postoperative day 1 and 7
timeFrame: 7 days after operation
measure: Postoperative hospital stay length
timeFrame: 60 days after operation
measure: Rehospitalization rate
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University
name: Danhua Yao, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.