Efficacy and Safety of Floseal for the Haemostasis During... | NCT01126281

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

NCT01126281

Sponsor

University of Bologna

Status

Unknown status

Last Update Posted

May 19, 2010Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Cholecystitis, Acute

Interventions

Laparoscopic Cholecystectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Aug 2013Estimated

Completion Date

Not provided

First Submitted Date

May 17, 2010

First Submission Date that Met QC Criteria

May 18, 2010

First Posted Date

May 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2010

Last Update Posted Date

May 19, 2010Estimated

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Floseal use	Experimental		Procedure: Laparoscopic Cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Cholecystectomy	Procedure	Laparoscopic cholecystectomy	Floseal use

Outcomes Module

Primary Outcomes

Measure	Description	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.		10 minutes

Secondary Outcomes

Measure	Description	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.		6 minutes
• Surgery time.		3 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fausto Catena, phD, MD	Contact	0039-0516363235		fausto.catena@aosp.bo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sant'Orsola-Malpighi Univesity Hospital		Bologna	Bologna	40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D041881	Cholecystitis, Acute

Ancestor Terms

ID	Term
D002764	Cholecystitis
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic

Ancestor Terms

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided