Perioperative Immunonutrition in Patients Undergoing Gynecologic or General Elective Surgery (PURPOSE)

NCT04057092 | Completed

• 1 other identifier: 2018-4462
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the implementation pilot is to assess the practicality of introducing a perioperative immunonutrition protocol into a hospital environment as well as a true measure of impact on the rate of surgical site infection (SSI).

Conditions

Surgical Site Infection; Post-Op Complication

Keywords

perioperative immunonutrition; clinical nutrition; infection prevention

Outcome Measures

Primary Outcomes (1)

• Rate of compliance to protocol

  a visual assessment of empty nutrition packages, to ensure patient has consumed 70% or more of the nutrition supplements

  5 days postoperative

Secondary Outcomes (2)

• Surgery site infection (SSI)

  30 days postoperative

• Length of hospital stay

  up to 12 weeks.

Study Arms (1)

Intervention group

EXPERIMENTAL

Eligible patients undergoing gynecologic oncology or general surgery will receive perioperative immunonutrition supplement INergy-FLD®. The operation should occur within 8 weeks from enrolment in the pilot study. Upon assessment and enrolment in the pilot study, patients will have a consultation with their physician in the preoperative clinic and will be provided with 10 days worth of INergy-FLD® beverages, 30 servings total.

Dietary Supplement: Dietary Supplement INergy-FLD

Interventions

Dietary Supplement INergy-FLD DIETARY_SUPPLEMENT

INergy-FLD® is an immune modulating formula containing various ingredients including L-Arginine, whey protein isolate, and omega-6 fatty acid, aimed to attenuate excessive inflammatory responses without being immunosuppressive and to replenish nutrients that are depleted in a state of surgical stress, thereby enhancing the recovery process and decreasing the risk of infection. The volume of the beverage is 250mL per serving and patients will be asked to consume 3 servings periodically per day for 5 days prior to surgery and 5 days following surgery.

Also known as: INergy-FLD®

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 years of age or older who are undergoing gynecologic oncology or general surgery (including resectable types of cancer) for which an elective operation is planned.
• Patients who are lactose intolerant are eligible for the study because the amount of lactose in INergy-FLD® is minimal (trace).

You may not qualify if:

• Cannot tolerate enteral intake
• Organ failure (liver, kidney)
• Patients currently on steroids
• Female patients who are pregnant and/or lactating
• Galactosemia

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Eligible and consenting gynecologic oncology and general surgery patients will receive EMN's nutritional supplement INergy-FLD® both before and after elective surgery.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 15, 2019
• Study Start: August 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)