Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm
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.
1 other identifier
interventional
216
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedJune 23, 2023
June 1, 2023
1.8 years
March 15, 2023
June 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical site infection (SSI)
Number of participants developing surgical site infections (SSI), defined as wound/parietal infection or intra-abdominal abscess without any anastomotic leak.
30 days after the surgical procedure
Secondary Outcomes (5)
Anastomotic leakage (AL)
30 days after the surgical procedure
Length of stay (LOS)
at 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
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
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
Study Arms (2)
A, Impact oral + Colorectal Surgery
ACTIVE COMPARATORthe 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.
B, Placebo group + Colorectal Surgery
PLACEBO COMPARATORA Placebo will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice.
Interventions
A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery
Oral Impact Nestle will be administered per os 3 times per day for 10 days before 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.
Eligibility Criteria
You may qualify if:
- primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
- to 85 years old, with no difficulties in oral intake
- BMI ranging from 18 to 40.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2023
First Posted
June 23, 2023
Study Start
July 1, 2023
Primary Completion
March 31, 2025
Study Completion
October 31, 2025
Last Updated
June 23, 2023
Record last verified: 2023-06