Suzanne S. Gisberts, MD, PhD Study Chair Amsterdam UMC Wietse J. Eshuis, MD, PhD Principal Investigator Amsterdam UMC Mark I. van Berge Henegouwen, MD, PhD Principal Investigator Amsterdam UMC
University Medical Center of the Johannes Gutenberg University Mainz (Rheinland-Pfalz) GermanyNoch nicht rekrutierend» Google-MapsAzienda Ospedaliera Universitaria Siena ItalyNoch nicht rekrutierend» Google-MapsAmsterdam UMC 1081 HV Amsterdam NetherlandsRekrutierend» Google-Maps
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1. Overall survival (Time Frame - 3 years after surgery): Overall survival is defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up
Secondary outcome:
1. 5-year overall survival (Time Frame - 5 years after surgery): Defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up
2. Intraoperative blood loss (Time Frame - Intraoperative): The volume of blood loss in milliliters during surgery
3. Postoperative complications (Time Frame - Within 30-days after surgery): Defined according to the Clavien-Dindo classification and comprehensive complication index (CCI)
4. Distribution of lymph node metastases (Time Frame - Pathology report 1/2 weeks after surgery): The distribution of lymph node metastases in gastric cancer
5. R0-resection rate (Time Frame - Pathology report 1/2 weeks after surgery): R0-resection rate of the distal and proximal margin, according to the College of American Pathologists
6. Rate of malignant cells in cytology (Time Frame - Pathology report 1/2 weeks after surgery): The proportion of patients with malignant cells in peritoneal lavage cytology
7. Molecular sub classification of gastric cancer (Time Frame - Pathology report 1/2 weeks after surgery): DNA methylation arrays will be used to classify the gastric tumor into molecular subtypes
8. Protocol compliance to allocated treatment (Time Frame - Up to 5 years): The proportion of patients who change from treatment arm
9. Hospital stay (Time Frame - Up to 5 year): Defined as time interval between date of surgery and date of hospital discharge
10. Readmission rate (Time Frame - Within 30-days after surgery): Rate of readmission
11. Reintervention rate (Time Frame - Within 30-days after surgery): Rate of reintervention
12. Reoperation rate (Time Frame - Within 3 years after surgery): Rate of reoperation
13. Quality of life assessment (Time Frame - At baseline, 3, 6, 9, 12 and 24 months): Quality of life is assessed using the EuroQol-5 Dimension (EQ-5D-5L) descriptive system.
14. 3- & 5-year disease-free survival (Time Frame - After 3 years and 5 years post-operative): Defined as the period of time from operation to locoregional recurrence, peritoneal recurrence, distant metastases, second gastric cancer or death from any cause. Patients alive and free of all these events will be censored at the last follow-up
15. Operative time (Time Frame - Intraoperative): The surgical procedure duration in minutes, defined as time from first incision to last wound closure.
16. Cost-effectiveness (Time Frame - Up to 3 years post-operative): Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies. The cost-effectiveness is compared by assessing cost per QALY.