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Table 2 Outcome parameters’ description

From: Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery

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