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

May 18, 2010 updated by: University of Bologna

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Sant'Orsola-Malpighi Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Floseal use
Procedure: Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (ESTIMATE)

May 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sant'orsola1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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