Table 1.
Trial visits and overview over documented parameters and outcomes
| Activity and documentation | Visit 1 (screening) |
Visit 2 (laparosc.) |
Visit 3 (surgery) |
Visits 4–6 (POD 1, 3, 5) |
Visit 7 (discharge) |
Visits 8–9 (POD 30, 90) | Visits 10–15 (POM 6, 12, 24, 36, 48, 60) |
| Inclusion and exclusion criteria | X | ||||||
| Informed consent | X | ||||||
| Medical history and preoperative assessment* | X | ||||||
| Randomisation | X | ||||||
| Surgical and anaesthetic documentation† | X | ||||||
| Postoperative morbidity measured with CCI (primary endpoint) until POD 30 | X | X | X | X | X (V8) | ||
| Biological specimen retrieval | |||||||
| EDTA blood samples | X | ||||||
| Formalin and paraffin tissue samples | X | ||||||
|
Visit 1 (screening) |
Visit 2 (laparosc.) |
Visit 3 (surgery) |
Visits 4–6 (POD 1, 3, 5) |
Visit 7 (discharge) |
Visits 8–9 (POD 30, 90) | Visits 10–15 (POM 6, 12, 24, 36, 48, 60) | |
| Short-term clinical endpoints | |||||||
| Postoperative morbidity measured with the CCI until POD 90 | X | X | X | X | |||
| Major complications (Clavien-Dindo ≥3) unitl POD 90 | X | X | X | X | |||
| Conversion rate | X | ||||||
| Operation time | X | ||||||
| Blood loss | X | ||||||
| Length of stay in the ICU | X | X | |||||
| Length of hospital stay | X | ||||||
| Pain and postoperative analgesic required | X | X | |||||
| Laboratory parameters (CRP, leucocytes) |
X | X | |||||
| Mobilisation of the patient | X | ||||||
| Quality of the patient’s recovery (QoR-15) | X (V5) | ||||||
| Quality of life (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADL) | X | X | X | X | |||
| Adherence to a fast-track gastrectomy SOP | X | X | X | ||||
| Objective evaluation of anastomoses | X | ||||||
| First bowl function | X | ||||||
| Wound healing deficits | X | X | X (V8) | ||||
| Vegetative function‡ | X | X | |||||
| Necessity of interventions due to complications | X | X | X | X | |||
| Oncological short-term data | |||||||
| No of lymph nodes removed and of tumour-positive lymph nodes | X | ||||||
| No of R0 resections | X | ||||||
| Development of tumour markers (CA 125, CA 19–9, CA 72–4, CEA) | X | ||||||
| Tumour histpathology§ | X | ||||||
| Long-term clinical data (5 year follow-up) |
|||||||
| Changes of body weight | X | X | X | ||||
| Quality of life (EUROQOL EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-STO22, ADL, BIS) | X | X | X | X | |||
| Incidence of incisional hernias | X | X | |||||
| Incidence of reoperations | X | X | X | X | |||
| Incidence of stenosis | X | X | |||||
| Cosmetic results and scar satisfaction (BIS) | X (V13) | ||||||
| Oncological long-term data (5-year follow-up) |
|||||||
| Oncological treatment (adjuvant and consecutive therapy) | X | X | |||||
| Disease-free survival recurrence-free survival, RFS | X (V9) | X | |||||
| Local recurrence | X (V9) | X | |||||
| RFS | X (V9) | X | |||||
| Progression-free survival | X (V9) | X | |||||
| Time to progression | X (V9) | X | |||||
| Overall survival | X (V9) | X |
*Includes body mass index, ASA status, preoperative oncological status, prior surgical treatment, drug use and comorbidities.
†Includes surgical documentation (surgeons, procedures, complications, drains) and anaesthesiology documentation.
‡Includes dysphagia, reflux and dumping syndromes.
§Includes entity, TNM, grading and resection status.
ADLs, activities of daily living; ASA, American Society of Anesthesiologists; BIS, Body Image Scale; CA, carbohydrate antigen; CCI, Comprehensive Complication Index; CEA, carcinoembryonic antigen; ECOG, Eastern Co-operative Oncology Group; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-STO22, EORTC Quality of Life Questionnaire for Gastric Cancer; EUROQOL EQ-5D-5L, EuroQol Group Questionnaire for Quality of Life with 5 dimensions and 5 levels; ICU, intensive care unit; POD, postoperative day; POM, postoperative month; QoR-15, Quality of Recovery 15; SOP, standard operating procedure.