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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Danhua Yao, Jinling Hospital, China.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778166
First Posted: January 29, 2013
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Danhua Yao, Jinling Hospital, China
  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
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

Further study details as provided by Danhua Yao, Jinling Hospital, China:

Primary Outcome Measures:
  • Time to tolerate IEEN/SEEN [ Time Frame: 30 days after operation ]

Secondary Outcome Measures:
  • Overall morbidity rate of IEEN/SEEN [ Time Frame: 60 days after operation ]
  • Mortality rate of IEEN/SEEN after operation [ Time Frame: 60 days after operation ]
  • Energy metabolism [ Time Frame: 10 days after operation ]
  • Time to the first postoperative adjuvant chemotherapy [ Time Frame: 30 days after operation ]
  • Nutritional status in postoperative day1and 7 of IEEN/SEEN [ Time Frame: 7 days after operation ]
  • Immune function in postoperative day 1 and 7 [ Time Frame: 7 days after operation ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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