Clinical trial NCT05916001: Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer of Colon
Nutrition Related Cancer
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infection (SSI)
timeFrame: 30 days after the surgical procedure
Secondary outcomes:
measure: Anastomotic leakage (AL)
timeFrame: 30 days after the surgical procedure
measure: Length of stay (LOS)
timeFrame: at patients' discharge
measure: Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
timeFrame: at the time of tissue analysis, usually 1 month after surgery
measure: grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
timeFrame: at the time of tissue analysis, usually 1 month after surgery
measure: Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)
timeFrame: at the time of tissue analysis, usually 1 month after surgery
Other outcomes:
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