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

Phase 4

• Conditions: Gastrointestinal Malignant
• Interventions: Drug: Standard early enteral nutrition; Drug: Immuno-enhanced

• Registration Number: NCT01778166
• Lead Sponsor: Jinling Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard early enteral nutrition	Standard early enteral nutrition	There would be 100 patients in this group
Immuno-enhanced early enteral nutrition	Immuno-enhanced	There would 100 patients in this group

Primary Outcome Measures

Name	Time	Method
Time to tolerate IEEN/SEEN	30 days after operation

Secondary Outcome Measures

Name	Time	Method
Overall morbidity rate of IEEN/SEEN	60 days after operation
Mortality rate of IEEN/SEEN after operation	60 days after operation
Energy metabolism	10 days after operation
Time to the first postoperative adjuvant chemotherapy	30 days after operation
Nutritional status in postoperative day1and 7 of IEEN/SEEN	7 days after operation
Immune function in postoperative day 1 and 7	7 days after operation
Postoperative hospital stay length	60 days after operation
Rehospitalization rate	30 days after discharge

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China