Cholecystitis, Acute
Conditions
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
Interventions
PROCEDURELaparoscopic Cholecystectomy
Laparoscopic cholecystectomy
Sponsors
University of Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| • 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 |
| • 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 |
| • Mortality. | 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 |
| • Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate). | 3 year |
Countries
Italy
Contacts
Primary ContactFausto Catena, phD, MD
Outcome results
None listed