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Trial Title:
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm
NCT ID:
NCT05916001
Condition:
Cancer of Colon
Nutrition Related Cancer
Conditions: Official terms:
Neoplasms
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Placebo
Description:
A Placebo will be administered per os 3 times per day for 10 days before colorectal
surgery
Arm group label:
B, Placebo group + Colorectal Surgery
Intervention type:
Dietary Supplement
Intervention name:
Oral Impact Nestle
Description:
Oral Impact Nestle will be administered per os 3 times per day for 10 days before
colorectal surgery
Arm group label:
A, Impact oral + Colorectal Surgery
Intervention type:
Procedure
Intervention name:
Colorectal surgery
Description:
Colorectal surgery will include right colectomy, left colectomy, transverse colectomy,
anterior rectal resection. All procedures will be performed according to the standard
clinical practice.
Arm group label:
A, Impact oral + Colorectal Surgery
Arm group label:
B, Placebo group + Colorectal Surgery
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
University of Roma La Sapienza
Agency class:
Other
Source:
University of Roma La Sapienza
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916001
