Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00576940
First received: December 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

December 18, 2007
December 18, 2007
June 2004
Not Provided
The ratio of postoperative complications (infectious and surgical) [ Time Frame: Postoperative complications ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • length of hospital stay [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
  • function of immune system [ Time Frame: function of immune system ] [ Designated as safety issue: No ]
  • assessment of liver and kidney function [ Time Frame: assessment of liver and kidney function ] [ Designated as safety issue: Yes ]
  • determination of the treatment tolerance [ Time Frame: determination of the treatment tolerance ] [ Designated as safety issue: Yes ]
  • assessment of visceral protein turnover [ Time Frame: assessment of visceral protein turnover ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Standard and Immunostimulating Enteral Nutrition in Surgical Patients
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Cancer
  • Pancreatic Cancer
  • Drug: Reconvan
    isocaloric, immunomodulating entral diet
    Other Name: oligopeptic immunostimulatory diet
  • Drug: Peptisorb
    isocaloric, isopeptic standard diet
    Other Name: standard enetral diet
  • Experimental: IMEN: 1
    Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
    Intervention: Drug: Reconvan
  • Active Comparator: SEN
    postoperative enteral nutrition - standard oligopeptic diet
    Intervention: Drug: Peptisorb

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
September 2007
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00576940
1st Dept Surg Enteral, Immunoenteral
No
1st Department of Surgery, Jagiellonian University
Jagiellonian University
Not Provided
Study Chair: Jan Kulig, MD, PhD 1st Department of General Surgery
Jagiellonian University
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP