Preoperative Immunonutrition in Normonourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.

Official Title
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Preoperative Immunonutrition Versus Standard Dietary Advice in Normo-nourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Immunonutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laparoscopic colorectal resection for cancer following ERAS protocol >18 years old elective setting Exclusion Criteria: age below 18 malnutrition inflammatory bowel disease acquired or congenital immunodeficiency preoperative infection ASA IV pregnancy emergency setting conversion to open surgery multivisceral resections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>patients receiving immunonutrition supply | Dietary Supplement: Immunonutrition<br>* nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery<br>|
| B<br>patients receiving standard dietary advice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | number of days between primary colorectal resection and discharge | up to 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to postoperative food intake | number of days between primary colorectal resection and refeeding | up to 30 days after discharge | 
| Time to first defecation | number of days between primary colorectal resection and first defecation | up to 30 days after discharge | 
| 30-days postoperative complications | Rate of any complication after colorectal resection | up to 30 days after discharge | 
| Surgical site infection | rate of any surgical site infection clinically demonstrated | up to 30 days after discharge | 
| Anastomotic leak | rate of any postoperative leakage of colo-rectal, colo-colic or ileo-colic anastomosis, clinically, radiologically or endoscopically demonstrated | up to 30 days after discharge | 
| Readmission | Rate of any unplanned readmission after discharge | up to 90 days after discharge | 
| 30-days Mortality | Rate of any mortality | up to 30 days after discharge | 
| Pneumonia | rate of radiologically demonstrated pneumonia | up to 30 days after discharge | 
| Ileus | rate of any ileus clinically demonstrated | up to 30 days after discharge | 
| Prolonged length of stay | rate of any patient discharged after 8 days | up to 30 days after discharge |