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OpenTrials
Completed

NCT Number: NCT04692545

Preoperative Immunonutrition in Normonourished 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunonutrition

Dietary Supplement

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

Primary outcomes

  1. Length of hospital stay

    Time frame: up to 30 days after discharge

    number of days between primary colorectal resection and discharge

Secondary outcomes

  1. Time to postoperative food intake

    Time frame: up to 30 days after discharge

    number of days between primary colorectal resection and refeeding

  2. Time to first defecation

    Time frame: up to 30 days after discharge

    number of days between primary colorectal resection and first defecation

  3. 30-days postoperative complications

    Time frame: up to 30 days after discharge

    Rate of any complication after colorectal resection

  4. Surgical site infection

    Time frame: up to 30 days after discharge

    rate of any surgical site infection clinically demonstrated

  5. Anastomotic leak

    Time frame: 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

  6. Readmission

    Time frame: up to 90 days after discharge

    Rate of any unplanned readmission after discharge

  7. 30-days Mortality

    Time frame: up to 30 days after discharge

    Rate of any mortality

  8. Pneumonia

    Time frame: up to 30 days after discharge

    rate of radiologically demonstrated pneumonia

  9. Ileus

    Time frame: up to 30 days after discharge

    rate of any ileus clinically demonstrated

  10. Prolonged length of stay

    Time frame: up to 30 days after discharge

    rate of any patient discharged after 8 days

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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