Skip to main content

Table 2 Assessment Schedule

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

  Study period
Event Pre-admission Pre-operative Intra-operative Post-operative
     During admission At discharge 30th POD 90th POD
Eligibility screen ≥ 1 day prior surgery       
Information - signed informed consent ≥ 1 day prior surgery       
Inclusion X       
Randomization    X     
Intervention - microdialysis    X X    
Control (standard care)    X X    
Start eCRF X       
Premedication   X      
Epidural   X      
Arterial catheter   X      
Central venous line   X      
Targeting anesthesia    SpO2 ≥ 93%. BPmap ≥ 60 mmHg. Body temperature ≥ 36 °C. Ventilatation with 6–8 ml/kg PBW     
Pantoperazole 40 mg iv     Administered daily for 7 days    
Assessments
Patient characteristics Gender, age, height, weight, BMI, blood pressure, heart rate, SpO2       
SOFA-score X    Daily until POD 10 if applicable    
Weight loss last 6 months X       
Concomitant medication X       
Smoking history Current, pack years       
Medical history Including pancreatitis       
Preoperative chemotherapy X       
Preoperative CT scan   X      
 Intraabdominal fat thickness   X      
 The relation to portal vein to tumor   X      
 Width of pancreatic duct   X      
 Width of pancreas   X      
 Current diseases Histology – differentiation of tumors and TNM staging X      
Quality of life questionnaire - Abdominal surgery Impact scale > 1 day before surgery. After inclusion but before randomization    POD 3 X X X
Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) > 1 days before surgery. After inclusion but before randomization    POD 3 X X X
Blood samples Hb, Trc, WBC, ASAT, ALAT, GGT, ALP, LD, Amylase, Bilirubin, Creatinine, Urea, GFR, CRP, a panel of inflammatory markers, s-lactate, and arterial blood gas.    Daily at 08.00 am: Hb, Trc, WBC, Amylase, ASAT, ALAT, GGT, LD, ALP, Bilirubin, Creatinine, GFR, UREA, CRP, a panel of inflammatory markers, s-lactate, arterial blood gas.    
iv fluid    X     
Urine output    X     
Blood loss    X     
Transfusion    X X    
Use of vasoactive medicaments    X     
Intraoperative PD width    X     
Intraoperative pancreatic consistency    X     
Histological assessment
Pancreatic fat    X     
Pancreatic fibrosis    X     
Drain tube    Insertion Cessation POD 1–3 (or more) unless the effluent is bile, enteric stained or turbid or depending on microdialysis concentrations    
Amylase and bilirubin in drain fluid     At POD 1–3 and on indication thereafter if drain still in place    
Pantoperazole 40 mg iv     Administered daily for 7 days    
Sampling/analyzing microdialysate     Every hour in the first 24 h. Thereafter, every two hours until POD 2. From POD 2: every 4th hour until discharge; Pyruvate, lactate, glucose, glycerol    
Collecting microdialysate for cytokines     Twice daily (≈ 08.00 am and 08.00 pm)    
Microdialysis catheter function and duration    X X    
Abdominal CT scan during admission(s)     POD 2 in patient with high microdialysate concentrations in three consecutive microdialysate samples and/or at the surgeon's discretion at the surgeons discretion at the surgeons discretion at the surgeons discretion
Postoperative complications - Clavien-Dindo classification ≥ 2     X X X X
Time from end of surgery to a diagnosed anastomosis leakage, if applicable     X X X X
Type of complications     X X X X
Type of procedures due to complications     X X X X
Cost of complications     X X X X
Transfer(s) to ICU     X X X X
LOS at primary hospital and ICU     X X X X
LOS at secondary hospital       X X
Mortality    X X X X X
  1. ALAT alanine aminotransferase, ALP alkaline phosphatase, ASAT aspartate aminotransferase, BMI body mass index, CRP c-reactive protein, CT computed tomography, GFR glomerular filtration rate, GGT gamma-glutamyl transferase, Hb hemoglobin, ICU intensive care unit, LD lactate dehydrogenase, LOS length of stay, PBW predicted body weight, PD pancreatic duct, POD postoperative day, SpO2 peripheral oxygen saturation, TNM tumor-nodule-metastasis, Trc platelets, WBC white blood cells