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

This study is not yet open for participant recruitment.

Verified May 2010 by University of Bologna

Sponsor:

Information provided by:

University of Bologna

ClinicalTrials.gov Identifier:

NCT01126281

First received: May 17, 2010

Last updated: May 18, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 17, 2010

Last Updated Date

May 18, 2010

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed. [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01126281 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• 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. [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]
• Surgery time. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate). [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Percentage of patients developing post operative bleeding leading to re-operation. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Percentage of patients developing post operative bleeding leading to transfusion of blood [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Percentage of patients developing post operative biliary leaking. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Time to drain removal. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Mortality. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Length of stay in hospital. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Cholecystitis, Acute

Intervention ^ICMJE

Procedure: Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy

Study Arm (s)

Experimental: Floseal use

Intervention: Procedure: Laparoscopic Cholecystectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Completion Date

Not Provided

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Fausto Catena, phD, MD

0039-0516363235

fausto.catena@aosp.bo.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01126281

Other Study ID Numbers ^ICMJE

Sant'orsola1

Has Data Monitoring Committee

Not Provided

Responsible Party

General, Emergency and Transplant Surgery dept., Sant'Orsola Malpighi University Hospital, Bologna, Italy

Study Sponsor ^ICMJE

University of Bologna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of Bologna

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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