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

This study is not yet open for participant recruitment.
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
History of Changes
  Purpose

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 Intervention Phase
Gastrointestinal Malignant
 Drug: Immuno-enhanced
Drug: Standard early enteral nutrition
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients

Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Time to tolerate IEEN/SEEN [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778166

Contacts
Contact: Danhua Yao, MD/PhD 8602580860961 yaodh87@gmail.com
Contact: Yousheng Li, MD/PhD 8602580860137 liys@medmail.com.cn

Locations
China, Jiangsu
Jinling Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210002
Contact: Danhua Yao, MD/PhD     8602580860037        
Principal Investigator: Danhua Yao            
Sponsors and Collaborators
Jinling Hospital, China
National Natural Science Foundation of China
Investigators
Principal Investigator: Danhua Yao, MD/PhD Nanjing University
  More Information

Publications:

Responsible Party: Danhua Yao, Senior Resident, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01778166     History of Changes
Other Study ID Numbers: ISEEN001, ISEEN
Study First Received: January 25, 2013
Last Updated: January 30, 2013
Health Authority: China: Ministry of Health

Keywords provided by Jinling Hospital, China:
Early enteral nutrition
Laparoscopic gastrointestinal surgery
Immuno-enhanced nutrition

ClinicalTrials.gov processed this record on May 19, 2013