Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)

December 18, 2007 updated by: Jagiellonian University

Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial

The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly assigned into two study groups: standard and immunostimulating. The study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background&Aim: The administration of immunomodulating enteral diets during postoperative period in patients after major gastrointestinal surgery is intended to reduce the number of postoperative complications and to shorten the hospital stay. The aim of the study was to assess the clinical effect of enteral immunostimulatory nutrition in surgical patients.

Material and Methods: 196 patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive early postoperative enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids) or oligopeptic control (SEN group) between June 2004 and September 2007. Enteral nutrition was started 6 hours after surgery and continued for 7 days, up to target volume of 100 ml/h. All malnourished patients requiring preoperative nutritional therapy were excluded for the study and treated preoperatively. Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function.

Results: One hundred eighty-three patients (91 in SEN, 92 in IMEN group, 69 F, 114 M, mean age 61.2) of 196 initially enrolled were analyzed. There were 2 deaths in both groups. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN group and 12.9 days (SD 8.0) in IMEN group (p=0.42). Complications were observed in 21 patients (23.1%) in SEN and 23 (25.2%) in IMEN group (p>0.05). 4 (4.4%) patients in SEN group and 4 (4.4%) in IMEN had surgical complications (p>0.05). There were no differences in liver and kidney function, visceral protein concentration and treatment tolerance.

Conclusion: Clinical and laboratory parameters show no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery as far as complications, hospital stay, mortality and treatment tolerance and safety are considered.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Krkaow
      • Krakow, Krkaow, Poland, 30-798
        • 1st Deparment of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18-80 years undergoing subtotal and total gastric resection with lymphadenectomy and pancreatoduodenectomy/ total pancreatectomy with lymphadenectomy, in good general status (Karnofsky > 80, Eastern Cooperative Oncology Group (ECOG) grade 0 or 1); with no confirmed neoplastic dissemination nor distant metastases
  • No severe concomitant disease (heart failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.)
  • No history of known allergies or drug intolerance

Exclusion Criteria:

  • Patients with metastatic or unresectable disease
  • Pregnant
  • In poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1)
  • With recent history of severe heart, lung, kidney or liver failure
  • With history of allergies or drug intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMEN: 1
Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
Drug: Reconvan
isocaloric, immunomodulating entral diet
Other Names:
  • oligopeptic immunostimulatory diet
Active Comparator: SEN
postoperative enteral nutrition - standard oligopeptic diet
Drug: Peptisorb
isocaloric, isopeptic standard diet
Other Names:
  • standard enetral diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ratio of postoperative complications (infectious and surgical)
Time Frame: Postoperative complications
Postoperative complications

Secondary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: length of hospital stay
length of hospital stay
function of immune system
Time Frame: function of immune system
function of immune system
assessment of liver and kidney function
Time Frame: assessment of liver and kidney function
assessment of liver and kidney function
determination of the treatment tolerance
Time Frame: determination of the treatment tolerance
determination of the treatment tolerance
assessment of visceral protein turnover
Time Frame: assessment of visceral protein turnover
assessment of visceral protein turnover

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Jan Kulig, MD, PhD, 1st Department of General Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1st Dept Surg Enteral
  • Immunoenteral

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