Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

University of Roma La Sapienza

Status: Not yet enrolling

Conditions: Cancer of Colon; Nutrition Related Cancer

Treatments: Procedure: Colorectal surgery; Dietary Supplement: Oral Impact Nestle; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05916001

7064/2023

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

A, Impact oral + Colorectal Surgery

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Oral Impact Nestle

Procedure: Colorectal surgery

B, Placebo group + Colorectal Surgery

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Colorectal surgery

Other: Placebo