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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692545
• Other study ID #: REGISTROSPERIMENTAZIONI /21
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Immunonutrition
nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	number of days between primary colorectal resection and discharge	up to 30 days after discharge
Secondary	Time to postoperative food intake	number of days between primary colorectal resection and refeeding	up to 30 days after discharge
Secondary	Time to first defecation	number of days between primary colorectal resection and first defecation	up to 30 days after discharge
Secondary	30-days postoperative complications	Rate of any complication after colorectal resection	up to 30 days after discharge
Secondary	Surgical site infection	rate of any surgical site infection clinically demonstrated	up to 30 days after discharge
Secondary	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
Secondary	Readmission	Rate of any unplanned readmission after discharge	up to 90 days after discharge
Secondary	30-days Mortality	Rate of any mortality	up to 30 days after discharge
Secondary	Pneumonia	rate of radiologically demonstrated pneumonia	up to 30 days after discharge
Secondary	Ileus	rate of any ileus clinically demonstrated	up to 30 days after discharge
Secondary	Prolonged length of stay	rate of any patient discharged after 8 days	up to 30 days after discharge