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Table 1 Primary and secondary objective. Primary, secondary, and other explorative endpoints and how they are assessed

From: Monitoring of patients with microdialysis following pancreaticoduodenectomy—the MINIMUM study: study protocol for a randomized controlled trial

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.
  1. AL anastomotic leakage, BMI body mass index, CT computed tomography, ICU intensive care unit, ISGLS International Study Group of Liver Surgery, ISGPF International Study Group on Pancreatic Fistula, iv intravenous, PD pancreatoduodenectomy, POD postoperative day, POPF postoperative pancreatic fistula