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Sponsors and Collaborators: |
Centre Hospitalier Universitaire de Nice National Cancer Institute, France |
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Information provided by: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT00825448 |
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
Condition | Intervention |
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Cancer of the Upper Aero-Digestive Tract Alcoholism |
Procedure: Hospitalization for a week |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer |
Estimated Enrollment: | 115 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
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Procedure: Hospitalization for a week
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
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1: No Intervention |
Alcohol, associated or not associated with tobacco, is known to increase the incidence of ORL cancer. So, in fact many patients perform their ORL surgery operation in spite of their alcohol addiction. 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eve GELSI, MD | +33 4 92 03 60 18 | gelsi.e@chu-nice.fr |
Contact: Albert TRAN, PhD | + 33 4 92 03 62 32 | tran.a@chu-nice.fr |
France | |
Fédération des maladies de l'appareil digestif - Hôpital ARCHET | |
NICE, France, 06202 |
Principal Investigator: | Albert TRAN, PhD | CHU de Nice |
Responsible Party: | CHU de Nice ( Département de la Recherche Clinique et de l'Innovation ) |
Study ID Numbers: | 2008-A00634-51 |
Study First Received: | January 20, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00825448 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee |
alcohol addiction |
Behavior, Addictive Mental Disorders Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders |