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

Primary Purpose

Cholecystitis, Acute

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sant'Orsola-Malpighi Univesity Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Floseal use

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
May 17, 2010
Last Updated
May 18, 2010
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01126281
Brief Title
Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Floseal use
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Description
Laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
• 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
Title
• Surgery time.
Time Frame
3 year
Title
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
Time Frame
3 year
Title
• Percentage of patients developing post operative bleeding leading to re-operation.
Time Frame
3 year
Title
• Percentage of patients developing post operative bleeding leading to transfusion of blood
Time Frame
3 year
Title
• Percentage of patients developing post operative biliary leaking.
Time Frame
3 year
Title
• Time to drain removal.
Time Frame
3 year
Title
• Mortality.
Time Frame
3 year
Title
• Length of stay in hospital.
Time Frame
3 year
Title
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fausto Catena, phD, MD
Phone
0039-0516363235
Email
fausto.catena@aosp.bo.it
Facility Information:
Facility Name
Sant'Orsola-Malpighi Univesity Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

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

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