Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial|
- The ratio of postoperative complications (infectious and surgical) [ Time Frame: Postoperative complications ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||June 2004|
|Study Completion Date:||September 2007|
Experimental: IMEN: 1
Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
isocaloric, immunomodulating entral diet
Other Name: oligopeptic immunostimulatory diet
Active Comparator: SEN
postoperative enteral nutrition - standard oligopeptic diet
isocaloric, isopeptic standard diet
Other Name: standard enetral diet
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576940
|1st Deparment of General Surgery|
|Krakow, Krkaow, Poland, 30-798|
|Study Chair:||Jan Kulig, MD, PhD||1st Department of General Surgery|