Alcohol Addiction and Otorhinolaryngology Cancer
Recruitment status was Recruiting
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.
Cancer of the Upper Aero-digestive Tract
Procedure: Hospitalization for a week
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer|
- 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 Frame: two weeks ] [ Designated as safety issue: No ]time between the surgery and the exit of the hospital
- The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications. [ Time Frame: two years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
patient in hospital a week before the date of surgery for the treatment of his addiction alcohol
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)
No Intervention: 1
no treatment of his addiction alcohol during a week before the date of surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825448
|Contact: Eve GELSI, MD||+33 4 92 03 60 email@example.com|
|Contact: Albert TRAN, PhD||+ 33 4 92 03 62 firstname.lastname@example.org|
|Fédération des maladies de l'appareil digestif - Hôpital ARCHET||Recruiting|
|Nice, France, 06202|
|Contact: Eve Gelsi, MD + 33 4 92 03 60 18 email@example.com|
|Contact: Albert Tran, PhD + 33 4 92 03 62 32 firstname.lastname@example.org|
|Principal Investigator: Albert Tran, PhD|
|Principal Investigator:||Albert TRAN, PhD||CHU de Nice|