Table 1.
Schedule of enrolment, interventions and assessments
| Study period | |||||||
|---|---|---|---|---|---|---|---|
| Enrolment and allocation | Post-allocation | Close-out | |||||
| Timepoint (months) | Surgery | Follow-up after surgery | |||||
| 0 | 1 | 2.5 | 4 | 7 | 13 | 25 | |
| Enrolment: | |||||||
| Eligibility screen | X | ||||||
| Informed consent | X | ||||||
| Allocation | X | ||||||
| Interventions: | |||||||
| MIE with cervical anastomosis | X | ||||||
| MIE with intrathoracic anastomosis | X | ||||||
| Assessments: | |||||||
| Baseline patient characteristics | X | ||||||
| Baseline tumour characteristics | X | ||||||
| QOL questionnaires | X | X | X | X | X | X | |
| CE questionnaires | X | X | X | X | X | ||
| Postoperative outcome data | X | ||||||
| Pathology data | X | ||||||
| Functional recovery data | X | X | X | X | X | X | |
| Oncologic follow-up data | X | X | X | X | X | ||
QOL quality of life, CE cost-effectiveness