Table 2.
Outcome parameters’ description
Domain | Specific measurements | Metric and time points for assessment | Method of aggregation |
---|---|---|---|
Primary outcomes | |||
Nutrition status | Body weight, kg | Change from baseline (V1) at1 day prior to discharge (V3); change from 1 day prior to discharge (V3) at 30 days after surgery (V4); change from 1 day prior to discharge (V3) at 90 days after surgery (V5) | Mean |
BMI, kg/m2 | |||
Serum albumin, g/L | |||
Serum prealbumin, mg/L | |||
Secondary outcomes | |||
Nutrition status | Handgrip strength, kgF | Change from baseline (V1) at 1 day prior to discharge (V3); change from 1 day prior to discharge (V3) at 30 days after surgery (V4); change from 1 day prior to discharge (V3) at 90 days after surgery (V5) | Mean |
Muscle mass, kg | |||
Fat mass, kg | |||
Serum transferrin, g/L | |||
Haemoglobin, g/dL | |||
Inflammation | High-sensitivity C-reactive Protein (hs-CRP), mg/L | Mean | |
Interleukin-6 (IL-6), pg/ml | |||
Salivary cortisol, μg/dL | |||
Dietary intake | Energy intake, kcal/d | Mean | |
Protein intake, g/d | |||
Sleep quality | Pittsburgh Sleep Quality Index (PSQI) score | Median | |
Postoperative complications | Postoperative complications | Frequency of postoperative complications at discharge (V3), at 30 days after surgery (V4), and 90 days after surgery (V5) | Median |
Length of hospital stay | Number of days of hospitalisation from admission (V1) to 1 day before discharge (V3) | Median |