Clinical trial NCT01126281: Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cholecystitis, Acute
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
timeFrame: 10 minutes
Secondary outcomes:
measure: • 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.
timeFrame: 6 minutes
measure: • Surgery time.
timeFrame: 3 year
measure: • Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
timeFrame: 3 year
measure: • Percentage of patients developing post operative bleeding leading to re-operation.
timeFrame: 3 year
measure: • Percentage of patients developing post operative bleeding leading to transfusion of blood
timeFrame: 3 year
measure: • Percentage of patients developing post operative biliary leaking.
timeFrame: 3 year
measure: • Time to drain removal.
timeFrame: 3 year
measure: • Mortality.
timeFrame: 3 year
measure: • Length of stay in hospital.
timeFrame: 3 year
measure: • Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
timeFrame: 3 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sant'Orsola-Malpighi Univesity Hospital
Study officials:
References: