Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
THE USE OF FLOSEAL GELATIN MATRIX FOR THE HAEMOSTASIS DURING LAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS; EFFICACY AND SAFETY EVALUATED IN A MULTICENTER, PROSPECTIVE, OPEN LABEL TRIAL WITH AN HISTORICAL CONTROL GROUP. (G.L.A. STUDY: GELATIN Matrix in Laparoscopic Cholecystectomy for Acute Cholecystitis)
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
to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
• 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.
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Patients aged 18 - 65 - Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of cholecystitis - Surgical indication for laparoscopic cholecystectomy - ASA class I-III - Informed consent - <72 hours from onset of symptoms Exclusion Criteria: - Informed consent refusal - Choledocholithiasis - Pre surgical generalized peritonitis (clinical evaluation) - ASA class > III - Peripheral artery disease - Active or past history of malignant systemic disease - Pregnant or lactating females - Known allergy to components Floseal including bovine allergy (bovine gelatin) - Known drug or alcohol abuse - Patients with known diabetes, chronic renal disease and other metabolic diseases - Patients in chronic cortisone treatment more than 2 years before surgery - Patients on chronic use of platelet inhibitors such as Aspirin, Plavix, NSAID's etc.
18 Years - 65 Years
Accepts Healthy Volunteers
, 0039-0516363235, [email protected]
University of Bologna