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).
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.
Project description:<h4>Background</h4> The efficacy of enteral immunonutrition (EIN) in patients undergoing gastrointestinal cancer surgery remains debatable. This meta-analysis aimed to investigate the effectiveness of EIN administration in patients undergoing surgery for gastrointestinal cancer. <h4>Methods</h4> From January 2000 to January 2022, PubMed, EMBASE, Cochrane Library, and Web of Science were thoroughly searched for randomized controlled trials (RCTs) with EIN versus standard diet or no supplement in patients undergoing surgery for gastrointestinal cancer. Overall complications and infectious complications were the primary outcomes. The secondary results were non-infectious complications, mortality, length of hospital stay, and enteral nutrition-related complications. <h4>Results</h4> Thirty-five studies reporting 3,692 patients undergoing surgery for gastrointestinal cancer (including gastric cancer, colorectal cancer, esophageal cancer, periampullary cancer, or pancreatic cancer) were included. Compared with the control group, EIN group had a significantly decreased incidence of overall complications (RR = 0.79, p < 0.001). Infectious complications in patients who received EIN were considerably lower than in the control group (RR = 0.66, p < 0.001). Compared to the control group, the incidence of surgical site infection, abdominal abscess, anastomotic leakage, bacteremia, duration of systemic inflammatory response syndrome (SIRS), and duration of antibiotic therapy was significantly lower in the specific infectious complications treated with EIN. Still, there was no significant difference between the two groups with other infectious complications. Moreover, a substantial shortening in the length of hospital stay was shown in EIN group compared with the control group. Still, no significant effect of EIN was demonstrated in non-infectious complicatios and mortality. The enteral nutrition-related complications had no significant difference between two groups. <h4>Conclusions</h4> EIN is safe and effective in reducing overall complications, infectious complications, and hospital stay in patients undergoing gastrointestinal cancer surgery (including gastric cancer, colorectal cancer, esophageal cancer, periampullary cancer, or pancreatic cancer).
Project description:Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after major gastrointestinal surgery, but its use in normo-nourished patients is still controversial. The primary aim of this comparative observational study was to evaluate if pre-operative IN reduces in-hospital stay in patients undergoing laparoscopic colorectal resection for cancer under an enhanced recovery after surgery (ERAS) program. The influence of IN on time to first bowel movements, time to full oral diet tolerance, number and type of complications, reasons of prolonged LOS and readmission rate was evaluated as secondary outcome. Patients undergoing ERAS laparoscopic colorectal resection between December 2016 and December 2019 were reviewed. Patients who have received preoperative IN (group A) were compared to those receiving standard dietary advice (group B). Mean in-hospital LOS was significantly shorter in patients receiving preoperative IN than standard dietary advice (4.85 ± 2.25 days vs. 6.06 ± 3.95 days; <i>p</i> < 0.0492). No differences in secondary outcomes were observed. Preoperative IN associated with ERAS protocol in normo-nourished patients undergoing laparoscopic colorectal cancer resection seems to reduce LOS.
Project description: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.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.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.Clinicaltrial.gov: NCT02041871.
Project description:<h4>Aim</h4>Evidence of nutritional therapies in pancreatoduodenectomy (PD) has been shown. However, few studies focus on the association between different nutritional therapies and outcomes. The aim of this review was to summarize the current evidence of nutritional therapies such as enteral nutrition (EN), immunonutrition, and synbiotics on postoperative outcomes after PD.<h4>Methods</h4>A systematic literature search of Embase, Medline Ovid, and Cochrane CENTRAL was done to summarize the available evidence, including randomized controlled trials, meta-analyses and reviews, regarding nutritional therapy in PD.<h4>Results</h4>A total of 20 randomized controlled trials were included in this review. Safety and tolerability of EN in PD was shown. Giving postoperative EN can shorten length of stay compared to parenteral nutrition; however, the effect of EN on postoperative complications remains controversial. Postoperative EN should be given only on selective indications rather than routinely used, and preoperative EN is indicated only in patients with severe malnutrition. Giving preoperative immunonutrition is considered to reduce the incidence of infectious complications; however, evidence level is moderate and recommendation grade is weak. The beneficial effect of perioperative synbiotics on postoperative infectious complications is limited. Furthermore, the effectiveness of other nutritional supplements remains unclear.<h4>Conclusion</h4>Recently, evidence of enhanced recovery after surgery (ERAS) in PD has been increasing. Early oral intake with systematic nutritional support is an important aspect of the ERAS concept. Future well-designed studies should investigate the impact of systematic nutritional therapies on outcomes following PD.
Project description:BACKGROUND:Infectious complications occur in 4-22 per cent of patients undergoing surgical resection of malignant solid tumours. Improving the patient's immune system in relation to oncological surgery with immunonutrition may play an important role in reducing postoperative infections. A meta-analysis was undertaken to evaluate the potential clinical benefits of immunonutrition on postoperative infections and 30-day mortality in patients undergoing oncological surgery. METHODS:PubMed, Embase and Cochrane Library databases were searched to identify eligible studies. Eligible studies had to include patients undergoing elective curative surgery for a solid malignant tumour and receiving immunonutrition orally before surgery, including patients who continued immunonutrition into the postoperative period. The main outcome was overall infectious complications; secondary outcomes were surgical-site infection (SSI) and 30-day mortality, described by relative risk (RR) with trial sequential analysis (TSA). Risk of bias was assessed according to Cochrane methodology. RESULTS:Some 22 RCTs with 2159 participants were eligible for meta-analysis. Compared with the control group, immunonutrition reduced overall infectious complications (RR 0·58, 95 per cent c.i. 0·48 to 0·70; I2 = 7 per cent; TSA-adjusted 95 per cent c.i. 0·28 to 1·21) and SSI (RR 0·65, 95 per cent c.i. 0·50 to 0·85; I2 = 0 per cent; TSA-adjusted 95 per cent c.i. 0·21 to 2·04). Thirty-day mortality was not altered by immunonutrition (RR 0·69, 0·33 to 1·40; I2 = 0 per cent). CONCLUSION:Immunonutrition reduced overall infectious complications, even after controlling for random error, and also reduced SSI. The quality of evidence was moderate, and mortality was not affected by immunonutrition (low quality). Oral immunonutrition merits consideration as a means of reducing overall infectious complications after cancer surgery.
Project description:Immunonutrition has been used to prevent the complications after colorectal elective surgery. This systematic review aimed to analyze and assess the effect of immunonutrition on colorectal cancer patients who received elective surgery.Three electronic databases (Medline, Embase, Cochrane) were used to search the latent studies which investigated the effects of enteral immunonutrition (EIN) compared with standard enteral nutrition (EN) or parenteral immunonutrition (PIN) compared with standard parenteral nutrition (PN) on colorectal cancer patients who are undergoing surgery until 21st of April, 2017. Meta-analysis was conducted to calculate odd risk (OR), mean difference (MD), or standard mean difference (SMD) with 95% confidence interval (CI), and heterogeneity was tested by Q test.Nine publications were included. The meta-analysis results presented that EIN improved the length of hospital stay (pooled MD, 2.53; 95% CI, 1.29-3.41), infectious complications (pooled OR, 0.33; 95% CI, 0.21-0.53) which contains the Surgical Site Infections (pooled OR, 0.25; 95% CI, 0.22-0.58) and Superficial/Deep incisional infections (pooled OR, 0.27; 95% CI, 0.12-0.64); meanwhile, PIN improved the length of hospital stay (pooled MD, 2.66; 95% CI, 0.62-4.76), IL-6 (pooled MD, -?6.09; 95% CI, -?10.11 to -?2.07), CD3 (pooled MD, 7.50; 95% CI, 3.57-11.43), CD4 (pooled MD, 5.47; 95% CI, 2.54-8.40), and CD4/CD8 (pooled MD, 0.50; 95% CI, 0.22-0.78); the level of CD8 was lower (pooled MD, -?4.32; 95% CI, -?7.09 to -?1.55) in PIN.Immunonutrition could be an effective approach to enhance the immune function of colorectal cancer patients undergoing elective surgery and to improve the clinical and laboratory outcomes.
Project description:Background and objectives: Immunonutrition is recommended by enhanced recovery after surgery in patients undergoing pancreatoduodenectomy for 5-7 days perioperatively as it may reduce the rate of infectious complications. However, data on effect of immunonutrition on the overall complication rate are contradictory and it is not clear, which groups of patients benefit most. The aims of this study are to evaluate the effects of immunonutrition on the overall complication rate and the rate of severe and/or multiple complications in patients with pancreatic tumours stratified according to final histological diagnosis-patients with pancreatic ductal adenocarcinoma (PDAC) vs. other tumours-and nutritional state, using more sensitive Comprehensive Complication Index. Materials and Methods: Seventy consecutive patients scheduled for pancreatoduodenectomy because of pancreatic tumours were randomised into immunonutrition vs. control groups and stratified according to final histological diagnosis and nutritional status. Surgical outcomes were assessed postoperatively using Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI). Results: No significant differences in the overall complication rates in immunonutrition vs. control, patients with malnutrition vs. no malnutrition, PDAC vs. other pancreatic tumours groups were detected. However, significant differences in the rates of severe and/or multiple complications in immunonutrition vs. control groups and in PDAC patients segregated according to immunonutrition were obtained using CCI. Conclusions: Patients with PDAC may experience greater benefits of immunonutrition as compared to patients with benign pancreatic diseases or less aggressive tumours, while nutritional status was not a determining factor for the efficacy of immunonutrition.
Project description:(1) Background: For normo-nourished colorectal cancer patients, the need for immunonutrients after elective surgery is not known. (2) Methods: Multicenter, randomized, double-blind, phase III clinical trial comparing the postoperative diet with 200 mL oligomeric hyperproteic normocaloric (OHN; experimental arm) supplement vs. 200 mL immunonutritional (IN) (active comparator) supplement twice a day for five days in 151 normo-nourished adult colorectal-resection patients following the multimodal rehabilitation ERAS protocol. The proportions of patients with complications (primary outcome) and those who were readmitted, hospitalized for <7 days, had surgical site infections, or died due to surgical complications (secondary outcome) were compared between the two groups until postoperative day 30. Tolerance to both types of supplement and blood parameters was also assessed until day 5. (3) Results: Mean age was 69.2 and 84 (58.7%) were men. Complications were reported in 41 (28.7%) patients and the incidence did not differ between groups (18 (25%) vs. 23 (32.4%) patients with OHN and IN supplement, respectively; <i>p</i> = 0.328). No significant differences were found for the rest of the variables. (4) Conclusions: IN supplement may not be necessary for the postoperative recovery of colorectal cancer patients under the ERAS regimen and with normal nutritional status at the time of surgery.
Project description:Perioperative immunonutrition in liver resection remains doubtful. A systematic review and meta-analysis was conducted to compare postoperative outcomes between patients undergoing hepatectomy who received perioperative immunonutrition and those who did not.A PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Knowledge database search was performed to retrieve all of the randomized controlled trials (RCTs) evaluating the value of perioperative immunonutrition in patients undergoing hepatectomy until the end of September 2016. Data extraction and quality assessment of RCTs were performed in accordance with PRISMA guidelines. The quality of evidence for each postoperative outcome was assessed using the GRADEpro analysis. A random-effects model was used to conduct a meta-analysis with RevMan 5.3.5 software. Eight RCTs including 805 patients (402 with and 403 without immunonutrition) were identified. Immunonutrition, mainly ?-3 fatty acids, significantly reduced the incidence of postoperative total complications (risk ratio [RR] = 0.59; 95% confidence interval [CI], 0.46-0.75; p < 0.0001) and infectious complications (RR = 0.46; 95% CI, 0.32-0.68; p < 0.0001), and shortened the length of hospital stay (standardized mean difference, -0.49; 95% CI, -0.81 to -0.16; p = 0.0004). There was no significant between-group difference in postoperative mortality (RR = 0.46; 95% CI, 0.16-1.31; p = 0.15). Immunonutrition, mainly ?-3 fatty acids, is potentially beneficial in reducing overall and infectious postoperative complications and in shortening the hospital stay for patients undergoing hepatectomy.
Project description:Importance:Novel approaches to perioperative surgical care focus on optimizing nutrition, mobility, and pain management to minimize adverse events after surgical procedures. Objective:To evaluate the outcomes of an enhanced recovery after surgery (ERAS) program among 2 target populations: patients undergoing elective colorectal resection and patients undergoing emergency hip fracture repair. Design, Setting, and Participants:A pre-post difference-in-differences study before and after ERAS implementation in the target populations compared with contemporaneous surgical comparator groups (patients undergoing elective gastrointestinal surgery and emergency orthopedic surgery). Implementation began in February and March 2014 and concluded by the end of 2014 at 20 medical centers within the Kaiser Permanente Northern California integrated health care delivery system. Exposures:A multifaceted ERAS program designed with a particular focus on perioperative pain management, mobility, nutrition, and patient engagement. Main Outcomes and Measures:The primary outcome was hospital length of stay. Secondary outcomes included hospital mortality, home discharge, 30-day readmission rates, and complication rates. Results:The study included a total of 3768 patients undergoing elective colorectal resection (mean [SD] age, 62.7 [14.1] years; 1812 [48.1%] male) and 5002 patients undergoing emergency hip fracture repair (mean [SD] age, 79.5 [11.8] years; 1586 [31.7%] male). Comparator surgical patients included 5556 patients undergoing elective gastrointestinal surgery and 1523 patients undergoing emergency orthopedic surgery. Most process metrics had significantly greater changes in the ERAS target populations after implementation compared with comparator surgical populations, including those for ambulation, nutrition, and opioid use. Hospital length of stay and postoperative complication rates were also significantly lower among ERAS target populations after implementation. The rate ratios for postoperative complications were 0.68 (95% CI, 0.46-0.99; P?=?.04) for patients undergoing colorectal resection and 0.67 (95% CI, 0.45-0.99, P?=?.05) for patients with hip fracture. Among patients undergoing colorectal resection, ERAS implementation was associated with decreased rates of hospital mortality (0.17; 95% CI, 0.03-0.86; P?=?.03), whereas among patients with hip fracture, implementation was associated with increased rates of home discharge (1.24; 95% CI, 1.06-1.44; P?=?.007). Conclusions and Relevance:Multicenter implementation of an ERAS program among patients undergoing elective colorectal resection and patients undergoing emergency hip fracture repair successfully altered processes of care and was associated with significant absolute and relative decreases in hospital length of stay and postoperative complication rates. Rapid, large-scale implementation of a multidisciplinary ERAS program is feasible and effective in improving surgical outcomes.