Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Malnutrition, Surgery

Intervention / Treatment
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* Other: Parenteral Nutrition
* Other: Standard Nutrition Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older 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: Patients undergoing minor or laparoscopic surgery Pregnancy Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V Patients with diabetes mellitus Patients with planned palliative treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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<br>* 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.<br>* Other names: Olimel 7.6% E 1000 ml;|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |