Lucyna Scislo

The immunomodulating enteral nutrition in malnourished surgical patients - a prospective, randomized, double-blind clinical trial.

BACKGROUND & AIM The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients, but many authors have questioned its value recently. The aim of the study was to assess the impact of enteral immunonutrition in postoperative period. METHODS Between January 2003 and December 2009, 305 malnourished patients (123 F, 182 M, m. age 60.8) undergoing resection for pancreatic or gastric cancer, after preoperative 14 days of parenteral feeding, were randomized in double-blind manner to receive either postoperative immunomodulating enteral diet (IMEN) or standard oligopeptide diet (SEN). Outcome measures of the intend-to-treat analysis were: number and type of complications, length of hospitalization, mortality, and vital organ function. RESULTS Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group (p = 0.006). Infectious complications were observed in 60 patients (39.2%) in SEN and 43 (28.3%) in IMEN group (p = 0.04). Differences were also observed in overall morbidity (47.1 vs 33.5%, p = 0.01) and mortality (5.9 vs 1.3%, p = 0.03), but the ratio of surgical complications, organ function, and treatment tolerance did not differ. CONCLUSIONS The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients. The Clinical Trials Database registry number: NCT00576940.

Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery – A prospective, randomized, controlled clinical trial

BACKGROUND & AIM The immunomodulating enteral diets are intended to reduce the incidence of postoperative complications in surgical patients. The aim of the study was to assess the clinical effect of such nutrition. MATERIALS AND METHODS Between June 2004 and September 2007 196 well-nourished patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive postoperative enteral nutrition with immunostimulating diet (IMEN group) or standard oligopeptic diet (SEN group). Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function. RESULTS One hundred and ninety six patients were initially enrolled, finally 183 patients (91 SEN, 92 IMEN group; 69 F, 114 M, median age 61.2) were analyzed. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN 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). Four (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 turnover and treatment tolerance. CONCLUSION Results of our study showed no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery. The Trial was registered in Clinical Trials Database--number: NCT00576940.

Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial

AIM Intravenous lipid emulsion (ILE) can become a risk factor for intestinal failure associated liver disease (IFALD). Many ILEs are commercially available, however, a direct comparison of their impact on liver has, to our knowledge, never been performed. The aim of the study was to analyse that clinical problem during long term parenteral nutrition (PN). METHODS A randomized, controlled clinical trial was performed at the Intestinal Failure Center in Skawina, Poland. Sixty-seven patients (37 F, 30 M, mean age 53.9 years) enrolled in home parenteral nutrition (HPN) due to stable chronic intestinal failure (CIF) were randomized to receive one the following for 12 months: long-chain triglycerides (LCT), medium/long-chain triglycerides, olive oil/LCT (OO/LCT) and a mix of LCT/MCT/OO/fish oil. Clinical evaluation and biochemical tests (total bilirubin, SGOT, SGTP, GGPT, alkaline phosphatase) were performed at enrolment and after 6 and 12 months. RESULTS the most common reason for intestinal failure (IF) was short bowel due to mesenteric ischaemia, followed by Crohns disease, surgical complications and radiation enteritis. PN stabilized liver parameters in all patients. No essential fatty acids deficiency was diagnosed. All four ILEs demonstrated comparable influence on liver in all study periods. The only exception was the decrease in total bilirubin concentration after 12 months (28.1 ± 25.3vs 11.1 ± 4.5, p = 0.0023) and GGTP (222.5 ± 205.8vs 146.6 ± 197.7, p = 0.0079) when OO/LCT was in use. CONCLUSIONS All four ILEs tested may be safe even during long-term parenteral nutrition. OO/LCT may be more effective than the others, but more studies in the field are needed.

The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients – Randomized Clinical Trial

ABSTRACT Background: Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients. Methods: A group of 98 gastric cancer patients was randomly assigned for postoperative immunomodulating enteral nutrition n = 44 (Reconvan, Fresenius Kabi, Bad Homburg, Germany), or standard enteral nutrition n = 54 (Peptisorb, Nutricia, Schipol, The Netherlands). Postoperative complications, mortality, 6-mo and 1-yr survival were analyzed. Results: The overall postoperative morbidity did not differ between the groups. The rate of pulmonary complications (excluding pneumonia) was significantly lower in immunomodulation group (0% vs 9.3%, p = 0.044), as well as 60-day mortality (0% vs. 11.1%, p = 0.037). There was no difference in 6-mo and 1-yr survival between the groups. Conclusions: Postoperative immunomodulating enteral nutrition may reduce respiratory complications and postoperative mortality in comparison to standard enteral nutrition. Despite this effect, it did not improve 6-mo and 1-yr survival in immunomodulation group. Probably the beneficial effect of immunomodulating enteral nutrition is too weak to be significant in such a number of patients.