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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