Table 2 Definition of secondary endpoints
Perioperative complications | Complication | Definition |
|---|---|---|
Bleeding | Severe intraoperative bleeding | Mentioned in operation report |
Perforation of hollow organs | Perforation of stomach, small intestine, colon or biliary tract/gallbladder | Mentioned in operation report |
Lesion in parenchymatous abdominal viscus | Lesion in liver, spleen, pancreas | Mentioned in operation report |
Postoperative complications | Complication | Definition |
Secondary bleeding/hematoma | postoperative bleeding | Need for more than 2 units of red blood cells within 24 hours after surgery OR Need of surgical treatment (mentioned in re-operation report) |
Hemtoma | Radiological (ultrasound, CT) findings positive for reoperation or reopening of the wound | |
wound infection | Deep and/or superficial according to CDC definition [20] | |
Gastroparesis | delayed gastric emptying (DGE) | Consensus definition of delayed gastric emptying after pancreatic surgery of the International Study Group of Pancreatic Surgery (ISGPS) [21] |
pp-Whipple specific complications | postoperative pancreatic fistula (POPF) | Drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of POPF (grades A, B, C) are defined according to the clinical impact on the patient's hospital course [22] |
Intraabdominal abscess | Intraabdominal collection of purulent or infected fluids (positiv bacterial culture) requiring radiological (puncture or drainage of purulent fluid) or surgical intervention (re-operation) | |
anastomotic leakage of choledochojejunostomy | Bilirubin-rich (more than 5000 units) drainage fluid of more than 50 ml per day on or after the 10th postoperative day OR Mentioned in re-operation report | |
anastomotic leakage of gastrojejunostomy | Radiological findings correlating to gastrojejunostomy insufficiency (e.g. CT with contrast medium withdrawal) OR Mentioned in re-operation report | |
Further secondary endpoints | Definition | |
Re-intervention | operational | Reoperation due to any cause |
interventional | Interventional haemostasis or drainages due to any cause | |
Intraoperative blood loss | Mentioned in operation report | |
Hospital stay | Time of admission to discharge | |
Re-hospitalization-rate | Re- hospilization within 30 days after surgery due to any cause | |
Duration of anesthesia | Mentioned in anesthesia report | |
Intraoperative material consumption | All materials, which are necessary for surgery | |
Material costs | Costs, which occurs due to the material consumption during the surgery | |
Overall costs | Costs include expenditure for personnel and use of operating room as well as for material consumption | |
Local recurrence of disease | Radiological (ultrasound, CT) findings positive for recurrence of disease | |
Quality of life | EORTC QLQ-C30, EORTC QLQ PAN26 and special questionnaire of the European Pancreas Center Heidelberg on day 30 (±10days), 90 (±10 days), 180 (±10 days), 1 year (± 1 month), 1,5 years (± 1 month), 2 years (± 1 month), 2,5 years (± 1 month) and 3 years (± 1 month) | |
Mortality rate | Death to any course until year 3 after operation |