| Trial name or title |
STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP‐OP Study) |
| Methods |
RCT |
| Participants |
Country of region: Denmark, 5 centres
N = 110
Age: 18 years
Sex: mixed
Clinical setting: urological surgery
Inclusion criteria
Patients scheduled for radical cystectomy for bladder cancer who smoke daily and/or drink at least 3 units of alcohol daily (1 unit contains 12 grams of ethanol)
Exclusion criteria
Cognitively unable to provide informed consent Allergy to disulfiram, benzodiazepines, or nicotine replacement therapy Pregnancy and breastfeeding
|
| Interventions |
Intensive intervention
Aimed to evaluate the effects of a smoking, alcohol, or combined cessation intervention started shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy Participants allocated to the intervention group receive 5 counselling sessions before, during, and after surgery over 6 weeks with trained smoking and alcohol cessation counsellors Smokers are offered a personalized nicotine replacement therapy (NRT) Risky drinkers are offered supportive medical treatment against development of mild to moderate withdrawal symptoms (chlordiazepoxide 10 mg, max times 10). Thiamine and B vitamins (300 mg × 7 weekly) Disulfiram (200 mg × 2 weekly) is given to support the alcohol stop
Control group
Treatment as usual (N = 55)
|
| Outcomes |
Primary outcomes
Follow‐up at 6 weeks, 3, 6, and 12 months Postoperative complications defined by death or postoperative morbidity requiring treatment
Secondary outcome
Type and grade of complications within 30 and 90 days after surgery assessed via the Clavien‐Dindo Classification of surgical complications (Clavien 2009)
|
| Starting date |
November 2014 |
| Contact information |
Susanne Vahr Lauridsen; phone: +45 35451704
Mail: susanne.vahr@regionh.dk |
| Notes |
ClinicalTrials.gov identifier: NCT02188446
|
