Piotr Szybinski

The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial.

Background and Aim:Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients. Material and Methods:Between June 1, 2001, and December 31, 2005, a group of 214 well-nourished patients was initially assessed (150 men, 64 women, mean age 61.2 years) to participate in the study. Nine patients were subsequently excluded and the remaining 205 subjects were randomly assigned in a 2 × 2 factorial design into 4 study groups, ie, standard enteral nutrition (n = 53), immunomodulating enteral nutrition (n = 52), standard parenteral nutrition (n = 49), and immunomodulating enteral nutrition (n = 51). The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. The study was registered in the Clinical Trials Database–number NCT 00558155. Results:The overall morbidity rate was 33% and the incidence of individual complications was comparable between all groups. Infectious complications occurred in 26 of 102 patients given standard diets and in 22 of 103 patients receiving immunomodulatory formulas (odds ratio 0.81; 95% CI, 0.43–1.50). There were no significant differences between infectious complications in patients using parenteral nutrition (22 of 100 patients) and parenteral formulas (26 of 105, odds ratio 1.14; 95% CI, 0.61–2.14). Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures, including overall morbidity and mortality rates, and hospital stay. Conclusions:Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery. Both enteral and parenteral treatment options showed similar efficacy, tolerance, and effects on protein synthesis. Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition. However, because of its cost-efficiency, enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy.

Enteral and Parenteral Nutrition in the Conservative Treatment of Pancreatic Fistula: A Randomized Clinical Trial

BACKGROUND & AIMS Postoperative pancreatic fistula is the most common and potentially life-threatening complication after pancreatic surgery. Although nutritional support is a key component of conservative therapy in such cases, there have been no well-designed clinical trials substantiating the superiority of either total parenteral nutrition or enteral nutrition. This study was conducted to compare the efficacy and safety of both routes of nutritional intervention. METHODS A randomized clinical trial was conducted in a tertiary surgical center of pancreatic and gastrointestinal surgery. Seventy-eight patients with postoperative pancreatic fistula were treated conservatively and randomly assigned to groups receiving for 30 days either enteral nutrition or total parenteral nutrition. The primary end point was the 30-day fistula closure rate. RESULTS After 30 days, closure rates in patients receiving enteral and parenteral nutrition were 60% (24 of 40) and 37% (14 of 38), respectively (P=.043). The odds ratio for the probability that fistula closes on enteral nutrition compared to total parenteral nutrition was 2.571 (95% confidence interval [CI]: 1.031-6.411). Median time to closure was 27 days (95% CI: 21-33) for enteral nutrition, and no median time was reached in total parenteral nutrition (P=.047). A logistic regression analysis identified only 2 factors significantly associated with fistula closure, ie, enteral nutrition (odds ratio=6.136; 95% CI: 1.204-41.623; P=.043) and initial fistula output of ≤200 mL/day (odds ratio=12.701; 95% CI: 9.102-47.241; P<.001). CONCLUSIONS Enteral nutrition is associated with significantly higher closure rates and shorter time to closure of postoperative pancreatic fistula.

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.

Commercial enteral formulas and nutrition support teams improve the outcome of home enteral tube feeding.

BACKGROUND The benefits of home enteral tube feeding (HETF) provided by nutrition support teams (NSTs) have been questioned recently, given the growing costs to the healthcare system. This study examined the effect of a specialized home enteral nutrition program on clinical outcome variables in HETF patients. METHODS The observational study included 203 patients (103 women, 100 men; mean age 52.5 years) receiving HETF with homemade diets for at least 12 months before starting a specialized home nutrition program for another 12 months consisting of provision of commercial enteral formulas and the guidance of an NST. Both study periods were compared regarding the number of hospital admissions, length of hospital and intensive care unit (ICU) stay, and costs of hospitalization. RESULTS A specialized HETF program significantly reduced the number of hospital admissions and the duration of hospital and ICU stays. The need for hospitalization and ICU admission was significantly reduced, with odds ratios of 0.083 (95% confidence interval, 0.051-0.133, P < .001) and 0.259 (95% confidence interval, 0.124-0.539, P < .001), respectively. Specialized HETF was associated with a significant decrease in the prevalence of pneumonia (24.1% vs 14.2%), respiratory failure (7.3% vs 1.9%), urinary tract infection (11.3% vs 4.9%), and anemia (3.9% vs 0%) requiring hospitalization. The average yearly cost of hospital treatment decreased from

Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study

764.65 per patient to

Perioperative nutrition in malnourished surgical cancer patients – A prospective, randomized, controlled clinical trial

142.66 per year per patient. CONCLUSIONS The specialized HETF care program reduces morbidity and costs related to long-term enteral feeding at home.

Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research.

BACKGROUND Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently. OBJECTIVE The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness. DESIGN The observational multicenter study in the group of 456 HEN patients [142 children: 55 girls and 87 boys, mean (±SD) age 8.7 ± 5.9 y; 314 adults: 151 women and 163 men, mean age 59.3 ± 19.8 y] was performed between January 2007 and July 2013. Two 12-mo periods were compared. During the first period, patients were tube fed a homemade diet and were not monitored; during the other period, patients received HEN. HEN included tube feeding and complex monitoring by a nutrition support team. The number of complications, hospital admissions, length of hospital stay, biochemical and anthropometric variables, and costs of hospitalization were compared. RESULTS Implementation of HEN enabled weight gain and stabilized liver function in both age groups, but it hardly influenced the other tests. HEN implementation reduced the incidence of infectious complications (37.4% compared with 14.9%; P < 0.001, McNemar test), the number of hospital admissions [1.98 ± 2.42 (mean ± SD) before and 1.26 ± 2.18 after EN; P < 0.001, Wilcoxons signed-rank test], and length of hospital stay (39.7 ± 71.9 compared with 11.9 ± 28.5 d; P < 0.001, Wilcoxons signed-rank test). The mean annual costs (

(99m)Tc-EDDA/HYNIC-octreotate - a new radiotracer for detection and staging of NET: a case of metastatic duodenal carcinoid.

) of hospitalization were reduced from 6500.20 ± 10,402.69 to 2072.58 ± 5497.00. CONCLUSIONS The study showed that HEN improves clinical outcomes and decreases health care costs. It was impossible, however, to determine precisely which factor mattered more: the artificial diet itself or the introduction of complex care.