In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage. To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
71
Hemopatch sealing hemostat used after LR to cover the resection surface
Medical University Vienna
Vienna, Austria
RECRUITINGBile leaks
biliary leak is defined as bilirubin concentration in the abdominal drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis
Time frame: 30 days
Bleeding
Postoperative bleeding that requires surgical intervention
Time frame: 30 days
Abscess
Abscess that requires surgical intervention or percutaneous drainage
Time frame: 30 days
Mortalitiy
Overall mortality within 30 days post liver resection
Time frame: 30 days
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