Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
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)
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedMay 19, 2010
May 1, 2010
3 years
May 17, 2010
May 18, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
• 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
- +5 more secondary outcomes
Study Arms (1)
Floseal use
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sant'Orsola-Malpighi Univesity Hospital
Bologna, Bologna, 40138, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 19, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2013
Last Updated
May 19, 2010
Record last verified: 2010-05