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

Cholecystitis, Acute Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01126281
• Other study ID #: Sant'orsola1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 17, 2010
• Last updated: May 18, 2010
• Start date: August 2010

Study information

• Verified date: May 2010
• Source: University of Bologna
• Contact: Fausto Catena, phD, MD
• Phone: 0039-0516363235
• Email: fausto.catena[@]aosp.bo.it
• Is FDA regulated: No
• Health authority: Italy ':'
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy

Locations

Country	Name	City	State
Italy	Sant'Orsola-Malpighi Univesity Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	• 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	Yes
Secondary	• Surgery time.		3 year	Yes
Secondary	• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).		3 year	Yes
Secondary	• Percentage of patients developing post operative bleeding leading to re-operation.		3 year	Yes
Secondary	• Percentage of patients developing post operative bleeding leading to transfusion of blood		3 year	Yes
Secondary	• Percentage of patients developing post operative biliary leaking.		3 year	Yes
Secondary	• Time to drain removal.		3 year	Yes
Secondary	• Mortality.		3 year	Yes
Secondary	• Length of stay in hospital.		3 year	Yes
Secondary	• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.		3 year	Yes