Cholecystitis, AcutePhase 4GLANCT01126281
Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)
A Phase 4 study testing Laparoscopic Cholecystectomy in people with Cholecystitis, Acute, run by University of Bologna at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2010to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Informed consent refusal
- Choledocholithiasis
- Pre surgical generalized peritonitis (clinical evaluation)
- ASA class > III
- Peripheral artery disease
- Active or past history of malignant systemic disease
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Conditions
- Cholecystitis, Acute
- Being tested
- Laparoscopic Cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Floseal use | Experimental | Not described Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
Measured: 10 minutes
Secondary outcomes (10)
• 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.
Measured: 6 minutes
• Surgery time.
Measured: 3 year
• Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).
Measured: 3 year
• Percentage of patients developing post operative bleeding leading to re-operation.
Measured: 3 year
• Percentage of patients developing post operative bleeding leading to transfusion of blood
Measured: 3 year
• Percentage of patients developing post operative biliary leaking.
Measured: 3 year
• Time to drain removal.
Measured: 3 year
• Mortality.
Measured: 3 year
• Length of stay in hospital.
Measured: 3 year
• Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126281
- Sponsor's protocol ID
- Sant'orsola1
- Acronym
- GLA
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 19 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01126281
- Acronym / sponsor ID
- GLA / Sant'orsola1
- Conditions
- Cholecystitis, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (estimated)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Floseal use | Experimental | Procedure: Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Informed consent refusal
- Choledocholithiasis
- Pre surgical generalized peritonitis (clinical evaluation)
- ASA class > III
- Peripheral artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic CholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Floseal use |
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
10 secondary outcomes
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Cholecystectomy in people with Cholecystitis, Acute, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fausto Catena, phD, MD (0039-0516363235, fausto.catena@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2010.