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Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576940
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : December 19, 2007
Information provided by:
Jagiellonian University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Gastric Cancer Pancreatic Cancer Drug: Reconvan Drug: Peptisorb Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial
Study Start Date : June 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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 Name: oligopeptic immunostimulatory diet

Active Comparator: SEN
postoperative enteral nutrition - standard oligopeptic diet
Drug: Peptisorb
isocaloric, isopeptic standard diet
Other Name: standard enetral diet

Primary Outcome Measures :
  1. The ratio of postoperative complications (infectious and surgical) [ Time Frame: Postoperative complications ]

Secondary Outcome Measures :
  1. length of hospital stay [ Time Frame: length of hospital stay ]
  2. function of immune system [ Time Frame: function of immune system ]
  3. assessment of liver and kidney function [ Time Frame: assessment of liver and kidney function ]
  4. determination of the treatment tolerance [ Time Frame: determination of the treatment tolerance ]
  5. assessment of visceral protein turnover [ Time Frame: assessment of visceral protein turnover ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576940

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1st Deparment of General Surgery
Krakow, Krkaow, Poland, 30-798
Sponsors and Collaborators
Jagiellonian University
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Study Chair: Jan Kulig, MD, PhD 1st Department of General Surgery

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: 1st Department of Surgery, Jagiellonian University Identifier: NCT00576940     History of Changes
Other Study ID Numbers: 1st Dept Surg Enteral
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: September 2007
Keywords provided by Jagiellonian University:
enteral nutrition, immunomodulating nutrition