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Table 1 Secondary endpoints of the CRUNSH Trial

From: C lamp-Cru shin g versus s tapler h epatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

Secondary endpoint Definition and assessment of outcomes
Blood loss during liver transection [mL] Blood loss from beginning of parenchymal transection until minor oozing is stopped. To assess blood loss during liver transection the suction device will be connected to a new suction container for the period of actual hepatic transection.
Blood transfusion: Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively. Documentation includes number of patients who received blood transfusions as well as amount of transfused packed red blood cells (PRBC) [units].
Operation time [min]: Time from skin incision to placement of last skin staple/suture.
Liver transection time [min]: Time from beginning to end of liver transection.
Duration of postoperative hospital stay [days]: Time from day of operation to day of discharge.
Duration of ICU stay [days]: Time on the Intensive Care Unit (ICU). Patients' stay in the recovery room and Intermediate Care (IMC) unit exceeding 24 hours is considered as ICU stay.
Morbidity: The following predefined complications are documented within the CRUNSH Trial:
Posthepatectomy hemorrhage [23]: Drop of hemoglobin level > 3 g/dl after the end of surgery compared to postoperative baseline level and/or any postoperative transfusion of PRBCs for a falling hemoglobin and/or the need for invasive re-intervention (e.g. embolization or re-laparotomy).
Postoperative biliary leakage [24]: Presence of bile fluid (bilirubin level more than three times the serum level) in the abdominal cavity or drains on or after postoperative day or the need for reintervention (i.e. interventional drainage and/or relaparotomy due to bile fluid collections or biliary peritonitis).
Further biliary complications: Biliary complications such as postoperative biliary stricture detected via ERCP and/or MRCP
Intraabdominal fluid collection/abscess: Intraabdominal fluid collection detected on any imaging modality (e.g. ultrasound, CT scan) associated with abdominal discomfort/pain and/or elevation of infectious parameters.
Posthepatectomy liver failure [25]: Increased INR or need of coagulation products (FFP, coagulation factors) to normalize the INR and increased serum bilirubin on or after postoperative day five.
Pneumonia: Pulmonary infection with evidence of increased infection parameters (CRP > 2 mg/dl and/or leukocytes > 10 0000/ml) which are unlikely to be caused by a different pathologic process and evidence of pulmonary infiltrates on chest x-ray, requiring antibiotic therapy.
In-hospital mortality: Death due to any reason within the patient's initial hospital stay.
Liver biochemical tests: Serum levels of Alanine-Aminotransferase (ALT), Aspartate-Aminotransferase (AST), Gamma-glutamyl transferase (GGT), Quick's time/INR, Total Bilirubin, Albumin on postoperative day 1, 3 and 5.
Need for portal triad clamping: Need for clamping of the hepatic pedicle to control intraoperative hemorrhage.
Resection margins The proportion of patients with malignant tumors who have a positive resection margin will be documented.
Need for invasive re-interventions: Invasive re-interventions such as placement of interventional drains, ERCP with stent placement and re-laparotomy within 30 days after the index operation or during patients' initial hospital stay.