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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.

SUBMITTER: Moya P

PROVIDER: S-EPMC4902354 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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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).

Moya Pedro P Soriano-Irigaray Leticia L Ramirez Jose Manuel JM Garcea Alessandro A Blasco Olga O Blanco Francisco Javier FJ Brugiotti Carlo C Miranda Elena E Arroyo Antonio A

Medicine 20160501 21

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 ...[more]

PMID: 27227930

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Project description:Background: Ovarian cancer is the third most common gynecological malignancy in the world and it is under a higher incidence of malnutrition. Chemotherapy is currently a common treatment for ovarian cancer, but the resulting side effects can exacerbate malnutrition. Our aim was to investigate the beneficial effects of oral nutrition supplements (ONS) on ovarian cancer patients undergoing chemotherapy. Methods: Single-blinded randomized controlled trial. Patients with ovarian cancer receiving chemotherapy were randomly assigned either to the ONS or non-ONS groups via a simple randomization. The ONS group was given 250 mL ONS each time (1.06 kcal, 0.0356 g of protein per mL), three times a day, and nutrition education. Control group received nutrition education alone. The primary outcome was the nutritional risk of the patients as assessed by the Patient-Generated Subjective Global Assessment (PG-SGA). The secondary outcome was the results of the participants' biochemical tests at each measurement time point. Data were collected (T0) at baseline, (T1) post intervention at 3 weeks, (T2) 9-week follow-up, (T3) 15-week follow-up. Generalized estimating equation models were used to compare the changes in outcomes over time between groups. Results: 60 participants (30 ONS, 30 controls) completed the trial, and data was analyzed. For baseline comparisons, no significant differences were found between the two groups. A progressive trend toward amelioration in PG-SGA scores over time was found within the ONS group, with scores decreasing from 9.27 ± 1.68 at baseline (T0) to 5.87 ± 2.06 after the intervention (T3). Furthermore, ONS group achieved a significantly greater reduction in PG-SGA score at the T1 (p = 0.03, confidence interval -2.23 to -0.11), T2 (p = 0.001, confidence interval -2.86 to -0.74) and T3 (p < 0.001, confidence interval -3.81 to -1.53), than the control group. In terms of biochemical test results, patients in the ONS group had better leukocytes, lymphocytes, Hemoglobin, Albumin and Total Protein than the control group at different time points, with statistical differences between the two groups (p < 0.05). Conclusions: The present study demonstrated that ONS can significantly reduce the nutritional risk of patients undergoing chemotherapy for ovarian cancer. In addition, we also found that nutritional education seems to have a positive effect on reducing the nutritional risk of patients especially at the beginning of chemotherapy.

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.

Dataset Information

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).

Publications

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).

Similar Datasets

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