Alcohol Addiction and Otorhinolaryngology Cancer
|ClinicalTrials.gov Identifier: NCT00825448|
Recruitment Status : Unknown
Verified December 2011 by Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : January 21, 2009
Last Update Posted : March 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Upper Aero-digestive Tract Alcoholism||Procedure: Hospitalization for a week||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||January 2013|
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
- 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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|