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

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Immunonutrition

• Registration Number: NCT04692545
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-06-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Immunonutrition	patients receiving immunonutrition supply

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 30 days after discharge	number of days between primary colorectal resection and discharge

Secondary Outcome Measures

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