Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm
- Conditions
- Cancer of ColonNutrition Related Cancer
- Registration Number
- NCT05916001
- Lead Sponsor
- University of Roma La Sapienza
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Surgical site infection (SSI) 30 days after the surgical procedure Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.
- Secondary Outcome Measures
Name Time Method Anastomotic leakage (AL) 30 days after the surgical procedure 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
grade of fibrosis in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) at the time of tissue analysis, usually 1 month after surgery 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.).
Length of stay (LOS) at patients' discharge 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
Inflammatory infiltration in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) at the time of tissue analysis, usually 1 month after surgery 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.).
Adipocytes cross sectional area (CSA) in the subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) at the time of tissue analysis, usually 1 month after surgery 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.).