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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: THE USE OF FLOSEAL GELATIN MATRIX FOR THE HAEMOSTASIS DURING LAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS; EFFICACY AND SAFETY EVALUATED IN A MULTICENTER, PROSPECT

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 Summary:
Sponsor: University of Bologna

Current 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. [ Time Frame: 10 minutes ]

Original Primary Outcome: Same as current

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


Original Secondary Outcome: Same as current

Information By: University of Bologna

Dates:
Date Received: May 17, 2010
Date Started: August 2010
Date Completion:
Last Updated: May 18, 2010
Last Verified: May 2010