Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02188446

Acronym

STOP-OP

Enrollment

105

Registered

2014-07-11

Start date

2014-11-30

Completion date

2018-07-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Consumption, Bladder Cancer, Smoking

Keywords

Radical cystectomy, Bladder cancer, Smoking cessation, Alcohol cessation, Postoperative complications

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALEducational programme for smoking and alcohol cessation

5 meetings within 6 weeks containing education and pharmacologic support

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Patients \> 18 years scheduled for cystectomy due to bladder cancer * Daily smoker or/and intake of -\>21 units (252 g) of alcohol pr week * Informed consent

Exclusion criteria

* Cancelled operation * Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement * Pregnant or breastfeeding women * Mentally incompetent patients

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with postoperative complications	Up to 6 weeks	Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured

Secondary

Measure	Time frame
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation	Up to 12 months postoperatively
Length of stay	From day of surgery to day of discharge
Postoperative complications	up to 90 days
Mortality	Up to 12 months postoperatively
Quality of life ( EORTC QLQ BLM 30 and EQ5D)	Up to 12 months postoperatively
Time to return to work or habitual level of activity	Up to 12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026