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

NCT04692545 | Completed

• 1 other identifier: REGISTROSPERIMENTAZIONI /21
• Study Type: observational
• Target: 173
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  number of days between primary colorectal resection and discharge

  up to 30 days after discharge

Secondary Outcomes (10)

• Time to postoperative food intake

  up to 30 days after discharge

• Time to first defecation

  up to 30 days after discharge

• 30-days postoperative complications

  up to 30 days after discharge

• Surgical site infection

  up to 30 days after discharge

• Anastomotic leak

  up to 30 days after discharge

Study Arms (2)

A

patients receiving immunonutrition supply

Dietary Supplement: Immunonutrition

B

patients receiving standard dietary advice

Interventions

Immunonutrition DIETARY_SUPPLEMENT

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• laparoscopic colorectal resection for cancer following ERAS protocol
• \>18 years old
• elective setting

You may not qualify if:

• age below 18
• malnutrition
• inflammatory bowel disease
• acquired or congenital immunodeficiency
• preoperative infection
• ASA IV
• pregnancy
• emergency setting
• conversion to open surgery
• multivisceral resections

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 5, 2021
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share