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

Phase 4

• Conditions: Cholecystitis, Acute
• Interventions: Procedure: Laparoscopic Cholecystectomy

• Registration Number: NCT01126281
• Lead Sponsor: University of Bologna

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Last Update Submitted: 2010-05-18
• Study First Posted: 2010-05-19
• Last Update Posted: 2010-05-19
• Study Start: 2010-08
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Floseal use	Laparoscopic Cholecystectomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Surgery time.	3 year
• Time to drain removal.	3 year
• Length of stay in hospital.	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
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.	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 transfusion of blood	3 year
• Mortality.	3 year
• Percentage of patients developing post operative bleeding leading to re-operation.	3 year
• Percentage of patients developing post operative biliary leaking.	3 year

Trial Locations

Locations (1)

Sant'Orsola-Malpighi Univesity Hospital; 🇮🇹 Bologna, Italy