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

Jinling Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Gastrointestinal Malignant

Treatments: Drug: Immuno-enhanced; Drug: Standard early enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01778166

ISEEN001

ISEEN (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard early enteral nutrition

Active Comparator group

Description:

There would be 100 patients in this group

Treatment:

Drug: Standard early enteral nutrition

Immuno-enhanced early enteral nutrition

Experimental group

Description:

There would 100 patients in this group

Treatment:

Drug: Immuno-enhanced