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 |