The aim of this study is to evaluate the effect and safety of Floseal in this preliminary prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute cholecystitis
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Laparoscopic cholecystectomy
Sant'Orsola-Malpighi Univesity Hospital
Bologna, Bologna, Italy
to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
Time frame: 10 minutes
• Percentage of patients with complete haemostasis evaluated at 2, 4 and 6 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
Time frame: 6 minutes
• Surgery time.
Time frame: 3 year
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
Time frame: 3 year
• Percentage of patients developing post operative bleeding leading to re-operation.
Time frame: 3 year
• Percentage of patients developing post operative bleeding leading to transfusion of blood
Time frame: 3 year
• Percentage of patients developing post operative biliary leaking.
Time frame: 3 year
• Time to drain removal.
Time frame: 3 year
• Mortality.
Time frame: 3 year
• Length of stay in hospital.
Time frame: 3 year
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
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Time frame: 3 year