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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
105
5 meetings within 6 weeks containing education and pharmacologic support
Department of Urology, University Hospital of Copenhagen
Copenhagen, Denmark
Number of patients with postoperative complications
Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured
Time frame: Up to 6 weeks
Postoperative complications
Time frame: up to 90 days
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
Time frame: Up to 12 months postoperatively
Length of stay
Time frame: From day of surgery to day of discharge
Time to return to work or habitual level of activity
Time frame: Up to 12 months
Mortality
Time frame: Up to 12 months postoperatively
Quality of life ( EORTC QLQ BLM 30 and EQ5D)
Time frame: Up to 12 months postoperatively
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