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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | patient in hospital a week before the date of surgery for the treatment of his addiction alcohol |
|
| 1 | No Intervention | no treatment of his addiction alcohol during a week before the date of surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospitalization for a week | Procedure | Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods. | time between the surgery and the exit of the hospital | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eve GELSI, MD | Contact | +33 4 92 03 60 18 | gelsi.e@chu-nice.fr | |
| Albert TRAN, PhD | Contact | + 33 4 92 03 62 32 | tran.a@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Albert TRAN, PhD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fédération des maladies de l'appareil digestif - Hôpital ARCHET | Recruiting | Nice | 06202 | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006760 | Hospitalization |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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