Objectives | Endpoints | Assessments | |
---|---|---|---|
Primary | To evaluate if the microdialysis method will reduce the total length of stay at the hospital(s). | Number of days/hours from end of surgery to hospital discharge from primary hospital plus number of days/hours for subsequent admissions with a diagnosis associated with the primary surgery at any hospital | Hours/days from the initial operation (end of surgery) to hospital discharge. All hospitals admitting the patient are included, also transferred hospitals. From electronic patient records. |
Secondary 1 | To evaluate predictive score systems for POPF | Occurrence of POPF | POPF defined according to the definition of the ISGPF. Graded into “biochemical”, B or C. From medical record, CT-scans. The following risk factors will be assessed: Age, gender, smoking history—current and package years, preoperative BMI, weight loss, Intraabdominal fat thickness, pancreatitis history, relation to portal vein to tumor, primary diagnosis, radiological (assessed by CT-scan) PD width, intraoperative PD width, intraoperative blood loss, pancreatic texture, pancreatic fat, pancreatic fibrosis, drain amylase. From preoperative examination, medical record, CT-scan, during surgery and postoperative examinations. |
Secondary 2 | To evaluate if microdialysis data contribute to reduced length of stay at the primary hospital and ICU | Length of stay at the primary hospital Length of stay at the ICU | Number of days/hours from end of initial operation to primary hospital discharge and hours admitted at the ICU. From electronic patient records. |
Secondary 3 | To evaluate if there is a special pattern of inflammatory markers in the microdialysate and serum in patients with/without POPF | Concentration of inflammatory markers | From laboratory analysis |
Secondary 4 | To evaluate the reliability and complications using microdialysis catheter CMA 65 | Occurrence of catheter malfunction Occurrence of bleedings and infections | Daily check of the microdialysis catheter is functioning. Assessments of bleeding which affects circulatory parameter (development of circulatory shock or need of transfusion) and infection |
Secondary 5 | To evaluate patient quality of life and pain | Overall score and sub-scale scores of patient-reported questionnaires | Two patient-reported questionnaires: “Abdominal surgery impact scale” will be gathered with patient-reported McGill Pain Questionnaire-2 (SF-MPQ-2) preoperatively, at POD3 ± 1 day and at discharge ± 2 days from primary hospital + 30 and 90 days after surgery. |
Secondary 6 | To compare hospital costs of using microdialysisis versus “standard of care” | Number of Euros per patient undergoing PD based on microdialysis costs, length of stay (ICU and inpatient stay), reoperations, and postoperative complications | From medical records, procedures noted in electronic patient records, and radiological electronic patient records. |
Exploratory | To compare other endpoints between patient with and without a microdialysis catheter | Hours from end of surgery to diagnosis of postoperative pancreatic AL (grades B and C). | Time as noted in electronic patient records. |
Total quantity (μg/mg) of vasoactive medications during surgery | Amount during surgery where the PD was performed. Derived from electronic patient records. | ||
Fluid balance - total iv volume administered and total diuresis | Diuresis and amount of fluid given iv during surgery and postoperatively until discharge from the hospital where the PD was performed. Derived from electronic patient records. | ||
Number of patients with biliary fistula | Biliary fistula defined according to the definition of the International Study Group of Liver Surgery (ISGLS). Graded into A, B, or C. From medical record, CT-scans. | ||
Number of patients with gastro-enteric AL | Gastro-enteric AL. From medical record, CT-scans. | ||
Pancreatic amylase and bilirubin concentrations in drainage fluid and in serum. | Analysis of drainage fluid and serum | ||
White blood cell count, C-reactive protein; concentrations | Laboratory data | ||
Number of patients with postoperative complications during total hospital stay in total and per complication | Defined by the modified Clavien-Dindo classification, from medical record, radiological examinations, and electronic patient records. | ||
Patient’s discharge disposition | From electronic patient records. |