Study Results
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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UNKNOWN
NA
115 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Many studies showed that a post surgery weaning syndrome increases morbidity and mortality.
So our study will focuses on the benefits of pre surgery medical weaning program.
The protocol is an open randomised, prospective study. The patient will be divided in two groups. In one hand, the first group is designed as "treated" will get alcohol weaning in the hospital alcohol department. The patient will be hospitalized during one week before the ORL surgery.
During this hospitalisation, the patient will receive medicinal treatment, medical follow-up and psychological counselling.
In the other hand, the second group designed as "control group" will be hospitalized directly in ORL surgery department. The patient will be received a treatment for alcohol weaning according to their symptom.
After their hospitalisation, the treated group will be followed-up regularly for their alcohol addiction either in support group or in individual counselling. The control group will be followed-up with the usual method in the ORL surgery department.
The expected result is to improve the care for patients with alcohol addiction and who must have an ORL surgery reducing the hospitalisation duration, the level of post operative complication and increasing the abstinence level. 115 patients will be included in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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2
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
Hospitalization for a week
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
1
no treatment of his addiction alcohol during a week before the date of surgery
No interventions assigned to this group
Interventions
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Hospitalization for a week
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
Eligibility Criteria
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Inclusion Criteria
* Clinically and histologically verified ORL cancer required surgery
* Patient with alcohol addiction
* Men must consume 21 glasses of wine a week
* Women must consume 14 glasses of wine a week
* CPAM affiliation
* Able to give written informed consent to participate in the study
Exclusion Criteria
* Patient with regulatory authority or private patient freedom
18 Years
80 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Department of Clinical Research and Innovation
OTHER
Responsible Party
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Department of Clinical Research and Innovation
Department of Clinical Research and Innovation (drc)
Principal Investigators
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Albert TRAN, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Locations
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Fédération des maladies de l'appareil digestif - Hôpital ARCHET
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2008-A00634-51
Identifier Type: -
Identifier Source: org_study_id
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