Domain | Specific measurement | Metric | Method of aggregation | Time point |
---|---|---|---|---|
Lumbar skeletal muscle index (LSMI) | The difference in lumbar skeletal muscle index (LSMI=height / area of skeletal muscle in cm2 at L3) derived from the third lumbar vertebral axial level | Change in LSMI at each time point | CT Scan; SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool | Pre-surgery 3 to 6 months post-surgery |
Visceral adipose tissue (VAT) Surface area | Visceral adipose tissue area (cm2) derived from the third lumbar vertebral axial level | Change in VAT at each time point | CT Scan; SliceOmatic software version 5.0 with ABACS L3 Plug-in automation tool | Pre-surgery 3 to 6 months post-surgery |
Systemic inflammation | C-Reactive Protein and serum albumin | Modified Glasgow Prognostic Score | Ordinal values mGPS=0 mGPS=1 mGPS=2 | Preoperatively and 6 months post-surgery |
Cellular immune response | Neutrophil count Lymphocyte count | Neutrophil to lymphocyte ratio (neutrophil/lymphocyte count | Clinically relevant categorical cut off values NLR<3 NLR>3 | Pre-operatively and 6 months post-surgery |
Post-operative complications | Any post-operative complication | Clavien-Dindo Classification | Clavien-Dindo Score 1–5 | Between 0 and 90 days post-surgery |
Length of hospital stay | Inpatient stay post-surgery | Days | Median length of stay | From surgery to hospital discharge |
Disease-free survival | Days to reported first recurrence / death / 5 years post-surgery | Days | Kaplan-Meier survival analysis | From date of surgery to 5 years post-surgery |
Overall survival | Days to death / 5 years post-surgery | Days | Kaplan-Meier survival analysis | From date of surgery to 5 years post-surgery |
Quality of life (General) | EuroQol 5-level EQ-5D5L Mobility, self-care, usual activities, | Visual analogue scale score 1–100 and score in each of the 5 domains | Change in scores between events | Pre-surgery, 6 and 12 months post-surgery |
Pain/discomfort and anxiety/depression | ||||
Quality of life (colorectal specific) | EORTC QLQ - CR29 Function and Symptoms | 4 multi-item scales and 19 single items assessing common symptoms and problems in colorectal cancer | Change in score between events | Pre-surgery, 6 and 12 months post-surgery |
Function | Berg Balance Scale (BBS) | Berg balance score (0–56) | Change in BBS score | Pre-surgery and 6 months post-surgery |
30 s sit to stand | Number of full sit-to stand actions completed in 30 s | Change in number of successful actions | ||
6-min walk test | Distance walked in 6 minutes | Change in metres | ||
Thigh circumference | Thigh circumference, 5cm above the superior pole of the patella | Circumference in cm | Change in thigh circumference between groups | |
Dose response to NMES | Pre- and post-operative mean muscle attenuation (L3) (MMA) and hours of device usage | Change in MMA/time | Linear regression | 3–6 months post-surgery |
Patient satisfaction | Free text responses and satisfaction scores derived from each domain (see patient satisfaction survey supplementary material). | Qualitative and visual analogue scale 1-10 | Qualitative responses Median score between groups on each domain assessed | 8 weeks post-surgery |
Bioimpedance analysis | Phase angle = (Xc/R)*180°/π | Cellular resistance (R) and cellular reactance (Xc) | Change in phase angle at each time point | Baseline, day 2 post operatively, day 28 postoperatively (if in hospital), day of discharge, first post-operative follow-up appointment |