Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- University of Alberta
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Rate of parenteral nutrition completion
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Rate of parenteral nutrition completion
Time Frame: through study completion, an average of 1 year
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
Postoperative complications evaluated by Clavien-Dindo Classification
Time Frame: through study completion, an average of 1 year
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
Secondary Outcomes
- Body weight(5-10 days during parenteral nutrition infusion)
- Muscle power(5-10 days during parenteral nutrition infusion)
- Total energy from parenteral nutrition(5-10 days during parenteral nutrition infusion)
- Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire(through study completion, an average of 1 year)
- Total protein from parenteral nutrition(5-10 days during parenteral nutrition infusion)
- Length of hospital stay(through study completion, an average of 1 year)
- Quality of life: Short Form (SF)-12 questionnaire(5-10 days during parenteral nutrition infusion)
- Nutrition status(5-10 days during parenteral nutrition infusion)
- Cost-saving(through study completion, an average of 1 year)
- Hospital readmission(30 days after discharge)