Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial.

BACKGROUND: Malnutrition is an independent risk factor of postoperative morbidity and mortality and it's observed in 20 to 50% of surgical patients. Preoperative interventions to optimize the nutritional status, reduce postoperative complications and enteral nutrition has proven to be superior to the parenteral one. Moreover, regardless of the nutritional status of the patient, surgery impairs the immunological response, thus increasing the risk of postoperative sepsis. Immunonutrition has been developed to improve the immunometabolic host response in perioperative period and it has been proven to reduce significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. We hypothesize that a preoperative oral immunonutrition (ORAL IMPACT®) can reduce postoperative morbidity in liver resection for cancer. METHODS/DESIGN: Prospective multicenter randomized placebo-controlled double-blind phase IV trial with two parallel treatment groups receiving either study product (ORAL IMPACT®) or control supplement (isocaloric isonitrogenous supplement--IMPACT CONTROL®) for 7 days before liver resection for cancer. A total of 400 patients will be enrolled. Patients will be stratified according to the type of hepatectomy, the presence of chronic liver disease and the investigator center. The main end-point is to evaluate in intention-to-treat analysis the overall 30-day morbidity. Secondary end-points are to assess the 30-day infectious and non-infectious morbidity, length of antibiotic treatment and hospital stay, modifications on total food intake, compliance to treatment, side-effects of immunonutrition, impact on liver regeneration and sarcopenia, and to perform a medico-economic analysis. DISCUSSION: The overall morbidity rate after liver resection is 22% to 42%. Infectious post-operative complications (12% to 23%) increase the length of hospital stay and costs and are responsible for a quarter of 30-day mortality. Various methods have been advocated to decrease the rate of postoperative complications but there is no evidence to support or refute the use of any treatment and further trials are required. The effects of preoperative oral immunonutrition in non-cirrhotic patients undergoing liver resection for cancer are unknown. The present trial is designed to evaluate whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for cancer. TRIAL REGISTRATION: Clinicaltrial.gov: NCT02041871.

[Complex approach to assessment of condition severity in patients with pyoinflammatory odontogenous diseases].

Dynamics of mean value indices and mean dispersion doesn't exclude the feedback (Mayanskiy D.N., 2008) in process of study the disease according to cooperative processes using system leukocyte-monocyte-lymphocyte (L+M+LM). The authors investigated a dynamic balance between these cell substratums and collagen formation. Acute inflammatory processes in tissues of maxillofacial area accompanied by leukemoid response of peripheral blood in the form of leukocytosis (10 x 10(9)-15 x 10(9)/l and more). The authors completely agree with the opinion of M.M. Solov'yov (2012) and N.K. Artyushenko (2008) that mechanism of this reaction is associated with both the leukocyte redistribution in the inflammation zone and with changes of hematopoietic rostock which aimed to balance the affected compensatory mechanisms of nonspecific resistance.

Optimizing surgical care: a contemporary assessment of temperature, oxygen, and glucose.

Factors such as temperature, oxygen, and glucose have recently been implicated in the development of surgical sepsis by either promoting or attenuating protective components of the innate immune response. Reducing infective sequelae and the improvement of the quality of care of surgical patients is a top practice priority today. These factors and their associated effects are discussed through the examination of recent clinical and scientific studies to provide an up-to-date evidence-based review.

Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery.

BACKGROUND: Specific immunonutrients may reduce the incidence of postoperative complications and shorten recovery time. This randomized trial evaluated the clinical efficacy of a fish oil emulsion on outcome and immune function after gastrointestinal cancer surgery. METHODS: A total of 206 patients with gastrointestinal or colonic cancer were randomized to receive isocaloric and isonitrogenous intravenous infusions of either soybean oil alone (1.2 g per kg bodyweight per day; control group, 103 analysed) or soybean plus fish oil emulsion (1.0 and 0.2 g per kg per day respectively; treatment group, 100 analysed) over 20-24 h daily for 7 days after surgery. RESULTS: Baseline data were comparable in the two groups. There were fewer infectious complications (four versus 12 on day 8; P = 0.066), systemic inflammatory response syndrome (SIRS) was significantly less common (four versus 13; P = 0.039) and hospital stay was significantly shorter (mean(s.d.) 15(5) versus 17(8) days; P = 0.041) in the treatment group. Total postoperative medical costs were comparable in the two groups (mean(s.d.) US $ 1269(254) and 1302(324) in treatment and control groups respectively; P = 0.424). The median (interquartile range) difference in CD4/CD8 between days 1 and 8 after surgery was + 0.30 (0.06 to 0.79) in patients receiving fish oil and + 0.20 (-0.19 to 0.55) in controls (P = 0.021). No severe adverse events occurred in either group. CONCLUSION: Fish oil emulsion-supplemented parenteral nutrition significantly reduced SIRS and length of hospital stay. These clinical benefits may be related to normalization of cellular immune functions and modulation of the inflammatory response.

[Immunologic assessment of the risk of developing infectious-inflammatory complications after percutaneous operations for nephrolithiasis]. / Immunologicheskaia otsenka riska razvitiia infektsionno-voxpalitel'nykh osloznenii posle perkutannyklh operatsii pri nefrolitiaze.

A retrospective comparison of the evidence obtained at preoperative examination of 68 patients with urolithiasis operated with the use of percutaneous technologies has demonstrated that the risk of postoperative infectious-inflammatory complications depends much on the immune status of the patient. Patients with initially different states of phagocytic immunity and antibody production had different courses of the postoperative period. An algorithm of immunological prediction of an acute pyelonephritis attack after percutaneous operations for nephrolithiasis is proposed.

New approaches to serious infections in the surgical patient.

The primary treatment of serious surgical infections involves a surgical procedure--debridement, drainage, or diversion--coupled with the adjunctive use of antibiotic therapy. Antibiotics are administered as prophylaxis, as presumptive therapy, or as precise therapy. Prophylactic antibiotics must be nontoxic, inexpensive, and have a broad spectrum of activity. It is also important that they not interfere with the primary treatment or the host defense. Antibiotics for presumptive therapy must be active against a wide range of presumed pathogens, but they are chosen primarily for their efficacy and secondarily for their lack of toxic and immunosuppressive effects. Because surgical infections are polymicrobial, standard therapy has consisted of a combination of antibiotics; monotherapy with an agent that is less toxic but as effective as combination therapy is a promising new approach to treatment.

Clinical assessment of host defense.

Host defense mechanisms are a determinant of infection. Anergy in surgical patients is a signal of broadly based immune deficits, which include abnormalities in specific and local nonspecific antibacterial defenses and related life-threatening sepsis. Analysis of these abnormalities and other risk factors allows us to generate a long-predictive equation of individual probability of death.

Characterization of neutrophil iodination for the assessment of phagocytic and opsonic function in septic patients.

To increase our understanding of the nature of surgical infection, further studies on the host defense abilities of infected patients are required. Therefore, a more thorough investigation of the iodination method for the measurement of polymorphonuclear leukocyte function and serum opsonic activity was undertaken to characterize its application in surgical infection. A significant relationship was found between the phagocytic indices derived from different standard neutrophils or sera measured on the same day. When expressed as a value of normal phagocytic indices minus abnormal phagocytic indices, this relationship was constant from day to day despite wide variations in the absolute phagocytic index values. This finding enables direct comparisons to be made between the values obtained both from the same patient and from different patients during the course of their illness by reference to daily control values. We also found that the system was sufficiently sensitive to detect, in a dose-responsive manner, the changes induced in normal neutrophil phagocytosis and serum opsonic activity by a specific bacterial challenge with either K. pneumoniae or E. coli. In addition, zymosan, which is utilized in the iodination reaction but also has immunoadjuvant properties, was found to enhance neutrophil function but depress serum opsonic activity in the face of such bacterial challenges. We conclude that the iodination technique is a credible method for the indirect measurement of polymorphonuclear phagocytosis and serum opsonic function in the face of a bacterial challenge and can be reliably employed in studies of septic patients provided these findings are taken into account.

[Assessment of postoperative infective risk by delayed hypersensitivity tests. The influence of deficient nutrition and its correction (author's transl)]. / Appréciation du risque infectieux post-opératoire par les tests d'hypersensibilité retardée. Influence de la dénutrition et de sa correction.

Cellular immunity was assessed in 120 patients by simple skin tests (tuberculin, candidine, varidase, C.C.B., trichophyton). There is a close relationship between total anergism and the risk of severe infection in digestive surgery, and between anergism and deficient nutrition as determined by laboratory and anthropometric criteria. Preoperative correction of nutritional deficiency, which is often underestimated, has an inconstant effect upon skin test responses, but seems to decrease severe postoperative infective complications.