Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
- Conditions
- MalnutritionSurgery
- Interventions
- Other: Standard Nutrition CareOther: Parenteral Nutrition
- Registration Number
- NCT03926949
- Lead Sponsor
- University of Alberta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group 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 Intervention group Parenteral Nutrition 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.
- Primary Outcome Measures
Name Time Method Rate of parenteral nutrition completion 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 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 Outcome Measures
Name Time Method Body weight 5-10 days during parenteral nutrition infusion Body weight measurement in kilograms
Muscle power 5-10 days during parenteral nutrition infusion Muscle power evaluated by handgrip strength test
Total energy from parenteral nutrition 5-10 days during parenteral nutrition infusion Total energy from parenteral nutrition measured by total energy in kilocalories per day multiply by total days of parenteral nutrition
Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire through study completion, an average of 1 year Acceptability, Appropriateness, and Feasibility Questionnaire included score 1 to 5
1. completely disagree with intervention
2. disagree with intervention
3. neither agree nor disagree with intervention
4. agree with intervention
5. completely agree with interventionTotal protein from parenteral nutrition 5-10 days during parenteral nutrition infusion Total protein from parenteral nutrition measured by total protein in grams per day multiply by total days of parenteral nutrition
Length of hospital stay through study completion, an average of 1 year Duration between hospital admission to discharge
Quality of life: Short Form (SF)-12 questionnaire 5-10 days during parenteral nutrition infusion 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.
Nutrition status 5-10 days during parenteral nutrition infusion 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.Cost-saving through study completion, an average of 1 year 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
Hospital readmission 30 days after discharge Readmission rate within 30 days after discharge
Trial Locations
- Locations (2)
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada