Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) (GLA)
Primary Purpose
Cholecystitis, Acute
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis, Acute
Eligibility Criteria
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.
Sites / Locations
- Sant'Orsola-Malpighi Univesity Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Floseal use
Arm Description
Outcomes
Primary Outcome Measures
to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
Secondary Outcome Measures
• 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.
• Surgery time.
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
• Percentage of patients developing post operative bleeding leading to re-operation.
• Percentage of patients developing post operative bleeding leading to transfusion of blood
• Percentage of patients developing post operative biliary leaking.
• Time to drain removal.
• Mortality.
• Length of stay in hospital.
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01126281
Brief Title
Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
Acronym
GLA
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bologna
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Floseal use
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Description
Laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
• 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
Title
• Surgery time.
Time Frame
3 year
Title
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
Time Frame
3 year
Title
• Percentage of patients developing post operative bleeding leading to re-operation.
Time Frame
3 year
Title
• Percentage of patients developing post operative bleeding leading to transfusion of blood
Time Frame
3 year
Title
• Percentage of patients developing post operative biliary leaking.
Time Frame
3 year
Title
• Time to drain removal.
Time Frame
3 year
Title
• Mortality.
Time Frame
3 year
Title
• Length of stay in hospital.
Time Frame
3 year
Title
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fausto Catena, phD, MD
Phone
0039-0516363235
Email
fausto.catena@aosp.bo.it
Facility Information:
Facility Name
Sant'Orsola-Malpighi Univesity Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
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Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
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