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Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications
Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.
The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
Department of Urology, University Hospital of Copenhagen
Copenhagen, Denmark
Start Date
November 1, 2014
Primary Completion Date
July 1, 2018
Completion Date
July 1, 2018
Last Updated
February 4, 2019
105
ACTUAL participants
Educational programme for smoking and alcohol cessation
BEHAVIORAL
Lead Sponsor
Rigshospitalet, Denmark
Collaborators
NCT07061964
NCT04235764
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT00026884