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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Jinling Hospital, China
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Danhua Yao, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01778166
First received: January 25, 2013
Last updated: January 30, 2013
Last verified: January 2013

January 25, 2013
January 30, 2013
February 2013
February 2014   (final data collection date for primary outcome measure)
Time to tolerate IEEN/SEEN [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778166 on ClinicalTrials.gov Archive Site
  • Overall morbidity rate of IEEN/SEEN [ Time Frame: 60 days after operation ] [ Designated as safety issue: Yes ]
  • Mortality rate of IEEN/SEEN after operation [ Time Frame: 60 days after operation ] [ Designated as safety issue: Yes ]
  • Energy metabolism [ Time Frame: 10 days after operation ] [ Designated as safety issue: No ]
  • Time to the first postoperative adjuvant chemotherapy [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]
  • Nutritional status in postoperative day1and 7 of IEEN/SEEN [ Time Frame: 7 days after operation ] [ Designated as safety issue: No ]
  • Immune function in postoperative day 1 and 7 [ Time Frame: 7 days after operation ] [ Designated as safety issue: No ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Gastrointestinal Malignant
  • 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
  • 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
  • Active Comparator: Standard early enteral nutrition
    There would be 100 patients in this group
    Intervention: Drug: Standard early enteral nutrition
  • Experimental: Immuno-enhanced early enteral nutrition
    There would 100 patients in this group
    Intervention: Drug: Immuno-enhanced

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
March 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Danhua Yao, MD/PhD 8602580860961 yaodh87@gmail.com
Contact: Yousheng Li, MD/PhD 8602580860137 liys@medmail.com.cn
China
 
NCT01778166
ISEEN001, ISEEN
Yes
Danhua Yao, Jinling Hospital, China
Jinling Hospital, China
National Natural Science Foundation of China
Principal Investigator: Danhua Yao, MD/PhD Nanjing University
Jinling Hospital, China
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP