Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

Cancer of Colon Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05916001
• Other study ID #: 7064/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2023
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: October 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms
• Neoplasms
• Nutrition Related Cancer

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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