Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
No
Albert TRAN, PhD
Principal Investigator
CHU de Nice
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2008-A00634-51
NCT00825448
January 2009
January 2013
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