Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parenteral Nutrition, Standard Nutrition Care.
- Who it may be relevant to
- Registry conditions: Malnutrition, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
Overview
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.
Interventions
- 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 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.
Primary outcome measures
- Rate of parenteral nutrition completion [Time frame: through study completion, an average of 1 year]
- Postoperative complications evaluated by Clavien-Dindo Classification [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (10)
- Length of hospital stay [Time frame: through study completion, an average of 1 year]
- Quality of life: Short Form (SF)-12 questionnaire [Time frame: 5-10 days during parenteral nutrition infusion]
- Body weight [Time frame: 5-10 days during parenteral nutrition infusion]
- Nutrition status [Time frame: 5-10 days during parenteral nutrition infusion]
- Muscle power [Time frame: 5-10 days during parenteral nutrition infusion]
- Cost-saving [Time frame: through study completion, an average of 1 year]
- Hospital readmission [Time frame: 30 days after discharge]
- Total energy from parenteral nutrition [Time frame: 5-10 days during parenteral nutrition infusion]
- Total protein from parenteral nutrition [Time frame: 5-10 days during parenteral nutrition infusion]
- Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire [Time frame: through study completion, an average of 1 year]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Royal Alexandra Hospital — Edmonton
- University of Alberta Hospital — Edmonton
Identifiers
NCT: NCT03926949 · 19G2208