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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04692545
Enrollment
173
Registered
2021-01-05
Start date
2016-12-01
Completion date
2020-06-01
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DIETARY_SUPPLEMENTImmunonutrition

nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayup to 30 days after dischargenumber of days between primary colorectal resection and discharge

Secondary

MeasureTime frameDescription
Time to first defecationup to 30 days after dischargenumber of days between primary colorectal resection and first defecation
30-days postoperative complicationsup to 30 days after dischargeRate of any complication after colorectal resection
Surgical site infectionup to 30 days after dischargerate of any surgical site infection clinically demonstrated
Anastomotic leakup to 30 days after dischargerate of any postoperative leakage of colo-rectal, colo-colic or ileo-colic anastomosis, clinically, radiologically or endoscopically demonstrated
Time to postoperative food intakeup to 30 days after dischargenumber of days between primary colorectal resection and refeeding
30-days Mortalityup to 30 days after dischargeRate of any mortality
Pneumoniaup to 30 days after dischargerate of radiologically demonstrated pneumonia
Ileusup to 30 days after dischargerate of any ileus clinically demonstrated
Prolonged length of stayup to 30 days after dischargerate of any patient discharged after 8 days
Readmissionup to 90 days after dischargeRate of any unplanned readmission after discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026