Table 2.
Event | Baseline/Pre‐op | Surgery | 3–5 days postop | 30 days postop | 4–6 weeks postop | 90 days postop | 1 year postop (UK only) | |
---|---|---|---|---|---|---|---|---|
Clinical assessments/investigations | Clinical examination | ✓ | ✓ | ✓ | ||||
Pre‐operative bloods | ✓ | |||||||
Operative details | ✓ | |||||||
Complications | ✓ | ✓ | ✓ | |||||
Trial consent | ✓ | |||||||
Microbiome sub‐study (faecal samples) | ✓ | ✓ | ✓ | |||||
Perfusion sub‐study (CTP and CTA) – OPTIONAL | ✓ | |||||||
Rectal contrast enema scan | ✓ | |||||||
Data collection time points | Eligibility CRF | ✓ | ||||||
Baseline CRF | ✓ | |||||||
Operative CRF | ✓ | |||||||
30 days postsurgery f/up CRF | ✓ | |||||||
90 days postsurgery f/up CRF | ✓ | |||||||
1 year postsurgery f/up CRF | ✓a | |||||||
Participant completed questionnaires | EQ‐5D‐5L | ✓ | ✓ | ✓ | ✓a | |||
EORTC QLQ‐C30 and QLQ‐CR29 | ✓ | ✓ | ✓ | ✓a | ||||
LARS | ✓ | ✓ | ✓ | |||||
Resource use (UK sites only) | ✓ | ✓ | ✓ |
CRF, case report form; CTA, CT angiography; CTp, perfusion CT; f/up, follow‐up; LARS, low anterior resection syndrome; postop, postoperative; Pre‐op, preoperative.
Only required if this time point falls before the end of the planned follow‐up period (i.e. 90 days following the last participant's operation).