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Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

NCT05916001 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-06-23

No results posted yet for this study

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.

Conditions

  • Cancer of Colon
  • Nutrition Related Cancer

Interventions

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-03-31
Completion
2025-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916001 on ClinicalTrials.gov