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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Bologna.
Recruitment status was  Not yet recruiting
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

May 17, 2010
May 18, 2010
August 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01126281 on ClinicalTrials.gov Archive Site
  • • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
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)

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cholecystitis, Acute
Procedure: Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy
Experimental: Floseal use
Intervention: Procedure: Laparoscopic Cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
Not Provided
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Fausto Catena, phD, MD 0039-0516363235 fausto.catena@aosp.bo.it
Italy
 
NCT01126281
Sant'orsola1
Not Provided
General, Emergency and Transplant Surgery dept., Sant'Orsola Malpighi University Hospital, Bologna, Italy
University of Bologna
Not Provided
Not Provided
University of Bologna
May 2010

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