Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients (OPPortuNity)

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study

Malnutrition is common in surgical patients. Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given by vein and can be safely provided to malnourished patients. It contains carbohydrates, fats, and protein just like you would normally in your diet. Pre-operative PN is able to improve outcomes in surgical patients. However, pre-operative PN has traditionally required hospital admission which results in increased length of stay, hospital cost, and hospital-acquired infection. Moreover, in hospital pre-operative PN may not be feasible or prioritized when access to inpatient surgery beds is limited. Outpatient PN provides the opportunity to solve this problem. The feasibility and impact of outpatient PN in malnourished patients undergoing major surgery have not previously been studied. This study aims to evaluate the feasibility of outpatient pre-operative PN and its effect on patient's outcomes.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; Surgery
• Intervention / Treatment: Other: Parenteral Nutrition; Other: Standard Nutrition Care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Narisorn Lakananurak, MD; Phone Number: 17808865718; Email: lakananu@ualberta.ca
• Study Contact Backup: Name: Leah Gramlich, MD; Phone Number: 17809204362; Email: lg3@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta Hospital
      • Contact: Narisorn Lakananurak, MD; Phone Number: 17808865718; Email: lakananu@ualberta.ca
      • Contact: Leah Gramlich, MD; Phone Number: 17809204362; Email: lg3@ualberta.ca
    • Edmonton, Alberta, Canada, T5H 3V9
      • Recruiting
      • Royal Alexandra Hospital
      • Contact: Narisorn Lakananurak, MD; Phone Number: 7808865718; Email: lakananu@ualberta.ca
      • Contact: Leah Gramlich, MD; Phone Number: 7809204362; Email: lg3@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients screened at risk of malnutrition by Canadian Nutrition Screening Tool (CNST) and identified as malnourished by subjective global assessment (SGA) B or C

Exclusion Criteria:

1. Patients undergoing minor or laparoscopic surgery
2. Pregnancy
3. Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V
4. Patients with diabetes mellitus
5. Patients with planned palliative treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Participants will receive parenteral nutrition (Olimel 7.6% E 1000 ml), infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.	Other: Parenteral Nutrition; Olimel 7.6% E 1000 ml will be infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.; Other Names: Olimel 7.6% E 1000 ml
Other: Control group; Participants will receive nutrition therapy by registered dietitians within 14 days prior to surgery. Patients with SGA B and SGA C will receive advanced nutrition care and specialized nutrition care, respectively	Other: Standard Nutrition Care; Participants will receive nutrition therapy by registered dietitians within 14 days prior to surgery. Patients with SGA B and SGA C will receive advanced nutrition care and specialized nutrition care, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of parenteral nutrition completion	Rate of parenteral nutrition completion calculated by the number of patients who can complete parenteral nutrition before surgery for 5-10 days divided by total number of patients in parenteral nutrition group	through study completion, an average of 1 year
Postoperative complications evaluated by Clavien-Dindo Classification	Clavien-Dindo Classification classifies postoperative complications into 5 grades (grade I to grade V) from mild to severe complications Grade I: no need specific intervention Grade II: need phamacological treatment Grade III: need surgical/endoscopic/radiological intervention Grade IV: life-threatening complications requiring ICU managment Grade V: death of a patient	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Duration between hospital admission to discharge	through study completion, an average of 1 year
Quality of life: Short Form (SF)-12 questionnaire	Quality of life evaluated by Short Form (SF)-12 questionnaire A mental component score (MCS-12) and a physical component score (PCS-12) are calculated by summation of mental and physical questions, respectively. The score range from 0-100, which the higher score means the better quality of life.	5-10 days during parenteral nutrition infusion
Body weight	Body weight measurement in kilograms	5-10 days during parenteral nutrition infusion
Nutrition status	Nutrition status evaluated by patient-generated subjective global assessment Patient-generated subjective global assessment divides a patient into 3 groups: A = well-nourished B = moderately malnourished or suspected malnutrition C = severely malnourished The total score is also calculated by summation of scores from weight, food intake, gastrointestinal symptoms, activity, metabolic demand, and physical examination. It ranges from 0-55, which the lower score means the better nutrition status.	5-10 days during parenteral nutrition infusion
Muscle power	Muscle power evaluated by handgrip strength test	5-10 days during parenteral nutrition infusion
Cost-saving	Difference in total length of stay (primary length of stay plus length of stay during readmission) between 2 groups multiplies by estimated unit cost of inpatient hospital stay per day from Alberta Health Service	through study completion, an average of 1 year
Hospital readmission	Readmission rate within 30 days after discharge	30 days after discharge
Total energy from parenteral nutrition	Total energy from parenteral nutrition measured by total energy in kilocalories per day multiply by total days of parenteral nutrition	5-10 days during parenteral nutrition infusion
Total protein from parenteral nutrition	Total protein from parenteral nutrition measured by total protein in grams per day multiply by total days of parenteral nutrition	5-10 days during parenteral nutrition infusion
Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire	Acceptability, Appropriateness, and Feasibility Questionnaire included score 1 to 5; completely disagree with intervention; disagree with intervention; neither agree nor disagree with intervention; agree with intervention; completely agree with intervention	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Leah Gramlich, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 19G2208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No