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

NCT ID: NCT01778166

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Gastrointestinal Malignant

Keywords

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Early enteral nutrition Laparoscopic gastrointestinal surgery Immuno-enhanced nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard early enteral nutrition

There would be 100 patients in this group

Group Type ACTIVE_COMPARATOR

Standard early enteral nutrition

Intervention Type DRUG

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

Immuno-enhanced early enteral nutrition

There would 100 patients in this group

Group Type EXPERIMENTAL

Immuno-enhanced

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Danhua Yao

Senior Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danhua Yao, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing University

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Danhua Yao, MD/PhD

Role: CONTACT

Phone: 8602580860961

Email: [email protected]

Yousheng Li, MD/PhD

Role: CONTACT

Phone: 8602580860137

Email: [email protected]

Facility Contacts

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Danhua Yao, MD/PhD

Role: primary

References

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Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.

Reference Type BACKGROUND
PMID: 21628607 (View on PubMed)

Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.

Reference Type BACKGROUND
PMID: 22788925 (View on PubMed)

Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.

Reference Type BACKGROUND
PMID: 21058198 (View on PubMed)

Other Identifiers

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ISEEN

Identifier Type: REGISTRY

Identifier Source: secondary_id

ISEEN001

Identifier Type: -

Identifier Source: org_study_id