Gastrointestinal Malignant
Conditions
Keywords
Early enteral nutrition, Laparoscopic gastrointestinal surgery, Immuno-enhanced nutrition
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.
Interventions
DRUGImmuno-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
DRUGStandard 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
Sponsors
National Natural Science Foundation of China
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to tolerate IEEN/SEEN | 30 days after operation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall morbidity rate of IEEN/SEEN | 60 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 |
| Nutritional status in postoperative day1and 7 of IEEN/SEEN | 7 days after operation |
Countries
China
Contacts
Primary ContactDanhua Yao, MD/PhD
Backup ContactYousheng Li, MD/PhD
Outcome results
None listed