Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Cholecystitis, Acute

Intervention / Treatment
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* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Floseal use<br> | Procedure: Laparoscopic Cholecystectomy<br>* Laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed. |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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. |  | 6 minutes | 
| • Surgery time. |  | 3 year | 
| • Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate). |  | 3 year | 
| • Percentage of patients developing post operative bleeding leading to re-operation. |  | 3 year | 
| • Percentage of patients developing post operative bleeding leading to transfusion of blood |  | 3 year | 
| • Percentage of patients developing post operative biliary leaking. |  | 3 year | 
| • Time to drain removal. |  | 3 year | 
| • Mortality. |  | 3 year | 
| • Length of stay in hospital. |  | 3 year | 
| • Safety evaluated as number of patients with adverse events and serious adverse events until end of the study. |  | 3 year |