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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Immunonutrition

• Study Type: Observational
• Enrollment (Actual): 173

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All normonourished patients undergoing elective ERAS laparoscopic colorectal resections for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; patients receiving immunonutrition supply	Dietary supplement: Immunonutrition; nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
B; patients receiving standard dietary advice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: REGISTROSPERIMENTAZIONI /21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No