Table 1.
Trial visits
| Activity and documentation | Visit 1 (screening) | Visit 2 (surgery) | Visits 3–9 (POD 1–7) | Visit 10 (discharge) | 1. Follow-up (POD 30) | 2. Follow-up (POD 90) | 3.-5. Follow-up (POM 12, 36, 60) |
|---|---|---|---|---|---|---|---|
| Inclusion and exclusion criteria and informed consent | x | ||||||
| Biometric data (*1) | X | ||||||
| Medical history and preoperative assessment (*2) | x | ||||||
| Oncological baseline data (*3) | x | ||||||
| Pain with VAS and analgetic management | x | x | x | ||||
| ASA, ECOG, Revised Cardiac Risk Index, lung function | x | ||||||
| Body weight | x | x | x | x | |||
| Randomization | x | ||||||
| Surgery | x | ||||||
| Surgical analgetic anesthetic documentation (*4) | x | ||||||
| Documentation of complications: | |||||||
| Dindo-Clavien for CCI within 30 POD | x | x | x | ||||
| Dindo-Clavien for CCI within 90 POD | x | x | x | x | |||
| further complications (*5) | x | x | x | x | x | ||
| scores | |||||||
| QoR-15 | x | x (on POD 7) | x | x | x | x | |
| SF-36 | x | x | x | x | x | ||
| EORTC QLQ-C30 and EORTC QLQ-OES18 | x | x | x | x | x | ||
| Perioperative course | |||||||
| Length of (single-lung-) ventilation and analgetic extubation | x | ||||||
| Epidural catheter management | x | x | |||||
| Hemodynamic medication | x | ||||||
| Fluid management | x | ||||||
| Blood gas analysis | x | ||||||
| Blood count and CRP | x | x (selectively) | |||||
| Catheters (peridural, urine, central venous) | x | ||||||
| Postoperative course | |||||||
| Adherence to fast track protocol | x | x | |||||
| Gastric tube and drainage management | x | x | |||||
| Mobilization | x | ||||||
| Vegetative functions (passing stool) | x | ||||||
| Wound healing/infection | x | ||||||
| Diet | x | x | x | ||||
| Length of hospital stay and discharge | x | ||||||
| Oncological and specific long-term | |||||||
| Histopathological data (*6) | x | ||||||
| GI symptoms (*7) | x | x | x | ||||
| Adjuvant therapy | x | x | x | ||||
| Disease-free survival | x | x | x | ||||
| Local recurrence | x | x | x | ||||
| Progression-free survival | x | x | x | ||||
| Overall survival | x | x | x | ||||
(*1) Including age, body height, and sex
(*2) Including medication and previous surgical intervention
(*3) Including first diagnosis, cTNM status, location relative to Z-line, and neoadjuvant chemo- or radiotherapy
(*4) Including surgeons, experience, procedure, operation time, anastomosis, complications, conversion, and drainages
(*5) Including anastomotic leak, conduit necrosis, chyle leak, and vocal cord injury according to ECCG and surgical site infection according to CDC
(*6) Including entity, pTNM, grading and resection status, number of lymph nodes retrieved, and number of tumor positive lymph nodes
(*7) Including dysphagia and reflux
ASA American Society of Anesthesiologists classification, CCI Comprehensive Complication Index coding complications and related interventions according to the Dindo-Clavien classification, CDC Center for Disease Control and Prevention, CRP C-reactive protein, ECCG Esophagectomy Complications Consensus Group, ECOG Eastern Cooperative Oncology Group score, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, EORTC QLQ-OES18 Computerized adaptive test European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Esophageal Cancer, POD postoperative day, POM postoperative month, QoR-15 Quality of Recovery 15, SF-36 Short-Form 36, VAS visual analog scale of pain. The primary endpoint is displayed in gray