Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)

University of Bologna

Status and phase

Unknown

Phase 4

Conditions

Cholecystitis, Acute

Treatments

Procedure: Laparoscopic Cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01126281

Sant'orsola1

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.