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

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Brief Title

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

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

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.

Secondary Outcome

 • 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.

Condition

Cholecystitis, Acute

Intervention

Laparoscopic Cholecystectomy

Study Arms / Comparison Groups

 Floseal use
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

August 2010

Primary Completion Date

August 2013

Eligibility Criteria

        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

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 0039-0516363235, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT01126281

Organization ID

Sant'orsola1

Study Sponsor

University of Bologna

Study Sponsor

, ,

Verification Date

May 2010