Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
---|---|---|---|---|---|---|---|---|
1–14 days before surgery | Day of surgery (day 0) | POD 4 | POD 8 | POD 12 | Day of hospital discharge | POD 30 | POD 90 | |
Outpatient/inpatient | Inpatient | Inpatient/telephone | ||||||
Eligibility criteria | X | |||||||
Informed consent | X | |||||||
Baseline demographics and clinical data | X | |||||||
Randomisation | X | |||||||
Quality of life questionnaire (SF-36) | X | X | X | |||||
Quality of recovery (QoR-15) | X | X | ||||||
Intervention | X | |||||||
Serious intraoperative complications | X | |||||||
Intraoperative secondary endpoints (e.g. operation time, blood loss, conversion rate, resection status) | X | |||||||
Surgeon’s mental workload/stress | X | |||||||
Assessment of primary endpoint (CCI) | X | X | X | X | X | X | ||
Postoperative secondary endpoints (e.g. re-interventions, pain, time to functional recovery) | X* | X | X | X | X | X | ||
Procedure-related costs, all inpatient hospital costs | X |