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Cola

the supplement Oral Impact will be administered 3 times a day for 10 days before the operation.

Colon surgery will be performed according to standard clinical practice.

A Placebo will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice.

A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery

Placebo

Oral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery

Oral Impact Nestle

Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.

Colorectal surgery

Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.

Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.

The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.

Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

Multicenter RCT on Effects of Preoperative Immunonutrition on Patients Undergoing Elective Colorectal Surgery for Neoplasm: Changes in Adipose Tissue Inflammation and Correlation With Surgical Outcome for Future ERAS Guidelines.

Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.

Number of participants developing anastomotic leakage (AL), defined as the evidence of leakage at the ileocolic or colo-colic or colo-rectal anastomosis, diagnosed with imaging modalities or with reoperation

Mean and Median Length of stay (LOS), defined as the mean and median number of days of hospitalization from the day of the surgical procedure to the day of patients' discharge

Number of inflammatory cells in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).

Number of fibroblasts in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).

Adipocytes cross sectional area (CSA) in the specimens of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT), as stated in a previous study published by the investigators (Molfino A, J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):333-342.).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm	NCT05916001	Cancer of Colon Nutrition Relat...	Placebo Oral Impact Nes... Colorectal surg...	20 Years - 85 Years	University of Roma La Sapienza
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm	NCT05916001	Cancer of Colon Nutrition Relat...	Placebo Oral Impact Nes... Colorectal surg...	20 Years - 85 Years	University of Roma La Sapienza
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm	NCT05916001	Cancer of Colon Nutrition Relat...	Placebo Oral Impact Nes... Colorectal surg...	20 Years - 85 Years	University of Roma La Sapienza

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