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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer of Colon; Nutrition Related Cancer
• Intervention / Treatment: Dietary supplement: Oral Impact Nestle; Procedure: Colorectal surgery; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
• 20 to 85 years old, with no difficulties in oral intake
• BMI ranging from 18 to 40.

Exclusion Criteria:

• emergency surgery,
• converted procedures,
• major intraoperative complications,
• concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
• synchronous cancer,
• previous bowel resections or bariatric surgery,
• presence of preoperative stoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A, Impact oral + Colorectal Surgery; 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.	Dietary supplement: Oral Impact Nestle; Oral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery; Procedure: Colorectal surgery; Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.
Placebo Comparator: B, Placebo group + Colorectal Surgery; 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.	Procedure: Colorectal surgery; Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.; Other: Placebo; A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection (SSI)	Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.	30 days after the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leakage (AL)	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	30 days after the surgical procedure
Length of stay (LOS)	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	at patients' discharge
Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)	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.).	at the time of tissue analysis, usually 1 month after surgery
grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)	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.).	at the time of tissue analysis, usually 1 month after surgery
Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)	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.).	at the time of tissue analysis, usually 1 month after surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 7064/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No