Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study)

Pedro Moya, Leticia Soriano-Irigaray, Jose Manuel Ramirez, Alessandro Garcea, Olga Blasco, Francisco Javier Blanco, Carlo Brugiotti, Elena Miranda, Antonio Arroyo, Pedro Moya, Leticia Soriano-Irigaray, Jose Manuel Ramirez, Alessandro Garcea, Olga Blasco, Francisco Javier Blanco, Carlo Brugiotti, Elena Miranda, Antonio Arroyo

Abstract

To compare immunonutrition versus standard high calorie nutrition in patients undergoing elective colorectal resection within an Enhanced Recovery After Surgery (ERAS) program.Despite progress in recent years in the surgical management of patients with colorectal cancer (ERAS programs), postoperative complications are frequent. Nutritional supplements enriched with immunonutrients have recently been introduced into clinical practice. However, the extent to which the combination of ERAS protocols and immunonutrition benefits patients undergoing colorectal cancer surgery is unknown.The SONVI study is a prospective, multicenter, randomized trial with 2 parallel treatment groups receiving either the study product (an immune-enhancing feed) or the control supplement (a hypercaloric hypernitrogenous supplement) for 7 days before colorectal resection and 5 days postoperatively.A total of 264 patients were randomized. At baseline, both groups were comparable in regards to age, sex, surgical risk, comorbidity, and analytical and nutritional parameters. The median length of the postoperative hospital stay was 5 days with no differences between the groups. A decrease in the total number of complications was observed in the immunonutrition group compared with the control group, primarily due to a significant decrease in infectious complications (23.8% vs. 10.7%, P = 0.0007). Of the infectious complications, wound infection differed significantly between the groups (16.4% vs. 5.7%, P = 0.0008). Other infectious complications were lower in the immunonutrition group but were not statistically significantly different.The implementation of ERAS protocols including immunonutrient-enriched supplements reduces the complications of patients undergoing colorectal resection.This study is registered with ClinicalTrial.gov: NCT02393976.

Conflict of interest statement

The authors have no funding and conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Flow diagram for the trial.

References

    1. Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg 2002; 183:630–641.
    1. Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg 2005; 92:3–4.
    1. Wind J, Polle SW, Fung Kon Jin PH, et al. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg 2006; 93:800–809.
    1. Adamina M, Kehlet H, Tomlinson GA, et al. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery 2011; 149:830–840.
    1. Spanjersberg WR, Reurings J, Keus F, et al. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev 2011; CD007635.
    1. Odermatt M, Miskovic D, Flashman K, et al. Major postoperative complications following elective resection for colorectal cancer decrease long-term survival but not the time to recurrence. Colorectal Dis 2015; 17:141–149.
    1. Lv L, Sao YF, Zhou YB. The enhanced recovery after surgery (ERAS) pathway for patients undergoing colorectal surgery: an update of meta-analysis of randomized controlled trials. Int J Colorectal Dis 2012; 27:1549–1554.
    1. Lohsiriwat V. Impact of an enhanced recovery program on colorectal cancer surgery. Asian Pac J Cancer Prev 2014; 15:3825–3828.
    1. Faist E, Kupper TS, Baker CC, et al. Depression of cellular immunity after major injury. Its association with posttraumatic complications and its reversal with immunomodulation. Arch Surg 1986; 121:1000–1005.
    1. Ramírez JM, Blasco JA, Roig JV, et al. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg 2011; 14:11.
    1. Esteban F, Cerdan FJ, Garcia-Alonso M, et al. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for colorectal cancer surgery. Colorectal Dis 2014; 16:134–140.
    1. Arroyo A, Ramirez JM, Callejo D, et al. Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Dis 2012; 27:1637–1644.
    1. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 2009; 250:187–196.
    1. Löhde E, Scholz L, Gemperle A, et al. Comparative analysis of mezlocillin/metronidazole and amoxicillin/clavulanic acid as “one shot” preventive antibiotic administration in colorectal interventions. Zentralbl Chir 1992; 117:325–330.
    1. Ostanin AA, Pal’tsev AV, Shalganova IG, et al. Cytokines in the treatment and prevention of postoperative infectious complications in patients with colorectal cancer. Vopr Onkol 1999; 45:612–616.
    1. Mynster T, Christensen IJ, Moesgaard F, et al. Effects of the combination of blood transfusion and postoperative infectious complications on prognosis after surgery for colorectal cancer. Danish RANX05 Colorectal Cancer Study Group. Br J Surg 2000; 87:1553–1562.
    1. Horzic M, Kopljar M. Postoperative infections in colorectal cancer patients. Hepatogastroenterology 2005; 52:101–104.
    1. Svendsen MN, Ytting H, Brünner N, et al. Preoperative concentrations of suPAR and MBL proteins are associated with the development of pneumonia after elective surgery for colorectal cancer. Surg Infect (Larchmt) 2006; 7:463–471.
    1. Jung B, Påhlman L, Nyström PO, Nilsson E. Mechanical Bowel Preparation Study Group. Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection. Br J Surg 2007; 94:689–695.
    1. Ruiz Tovar J, Badia JM. Prevention of surgical site infection in abdominal surgery. A critical review of the evidence. Cir Esp 2014; 92:223–231.
    1. Crombe T, Bot J, Messager M, et al. Malignancy is a risk factor for postoperative infectious complications after elective colorectal resection. Int J Colorectal Dis 2016; 31:885–894.
    1. Alfonsi P, Slim K, Chauvin M, et al. Guidelines for enhanced recovery after elective colorectal surgery. Ann Fr Anesth Reanim 2014; 33:370–384.
    1. Hegazi RA, Hustead DS, Evans DC. Preoperative standard oral nutrition supplements vs immunonutrition: results of a systematic review and meta-analysis. J Am Coll Surg 2014; 219:1078–1087.
    1. Maung AA, Davis KA. Preoperative nutritional support immunonutrition, probiotics and anabolic steroids. Surg Clin North Am 2012; 92:273–283.
    1. Marimuthu K, Varadhan KK, Ljungqvist O, et al. A meta-analysis of the effect of combinations of immune modulating nutrients on outcome in patients undergoing major open gastrointestinal surgery. Ann Surg 2012; 255:1060–1068.
    1. Heys SD, Walker LG, Smith I, et al. Enteral nutritional supplementation with key nutrients in patients with critical illness and cancer: a meta-analysis of randomized controlled clinical trials. Ann Surg 1999; 229:467–477.
    1. Waitzberg DL, Saito H, Plank LD. Postsurgical infections are reduced with specialized nutrition support. World J Surg 2006; 30:1592–1604.
    1. Osland E, Hossain MB, Khan S, et al. Effect of timing of pharmaconutrition (immunonutrition) administration on outcomes of elective surgery for gastrointestinal malignancies: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr 2014; 38:53–69.
    1. Braga M, Gianotti L, Radaelli G, et al. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg 1999; 134:428–433.
    1. Braga M, Gianotti L, Vignali A, et al. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery 2002; 132:805–814.
    1. Horie H, Okada M, Kojima M, et al. Favorable effects of preoperative enteral immunonutrition on a surgical site infection in patients with colorectal cancer without malnutrition. Surg Today 2006; 36:1063–1068.
    1. Helminen H, Raitanen M, Kellosalo J. Immunonutrition in elective gastrointestinal surgery patients. Scand J Surg 2007; 96:46–50.
    1. Sorensen LS, Thorlacius-Ussing O, Schmidt EB, et al. Randomized clinical trial of perioperative omega-3 fatty acid supplements in elective colorectal surgery. Br J Surg 2014; 101:33–42.
    1. Finco C, Magnnini P, Sarzo G, et al. Prospective randomized study on perioperative enteral immunonutrition in laparoscopic colorectal surgery. Surg Endosc 2007; 21:1175–1179.
    1. Tatsumi H, Ura H, Ikeda S, et al. Surgical influence on TH1/TH2 balance and monocyte surface antigen expression and its relation to infectious complications. World J Surg 2003; 27:522–528.
    1. Matsuda A, Furukawa K, Takasaki H, et al. Preoperative oral immune-enhancing nutritional supplementation corrects TH1/TH2 imbalance in patients undergoing elective surgery for colorectal cancer. Dis Colon Rectum 2006; 49:507–516.
    1. Compliance E.R.A.S Group. The impact of Enhanced Recovery Protocol Compliance on elective colorectal cancer resection: results from an international registry. Ann Surg 2015; 261:1153–1159.
    1. Nicholson A, Lowe MC, Parker J, et al. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg 2014; 101:172–188.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅