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

NCT ID: NCT01126281

Last Updated: 2010-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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

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Conditions

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Cholecystitis, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Floseal use

Group Type EXPERIMENTAL

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Interventions

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Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Sant'Orsola Malpighi University Hospital, Bologna, Italy

Locations

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Sant'Orsola-Malpighi Univesity Hospital

Bologna, Bologna, Italy

Site Status

Countries

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Italy

Central Contacts

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Fausto Catena, phD, MD

Role: CONTACT

0039-0516363235

Other Identifiers

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Sant'orsola1

Identifier Type: -

Identifier Source: org_study_id

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