Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
NCT ID: NCT01126281
Last Updated: 2010-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Floseal use
Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy
Interventions
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Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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Sant'Orsola Malpighi University Hospital, Bologna, Italy
Locations
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Sant'Orsola-Malpighi Univesity Hospital
Bologna, Bologna, Italy
Countries
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Central Contacts
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Other Identifiers
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Sant'orsola1
Identifier Type: -
Identifier Source: org_study_id
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