Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol Consumption | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Smoking | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational programme for smoking and alcohol cessation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Smoking and alcohol cessation education
- interventionNames
- Behavioral: Educational programme for smoking and alcohol cessation
- type
- NO_INTERVENTION
- label
- Standard treatment
- description
- Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.
Primary outcomes (1)
- measure
- Number of patients with postoperative complications
- timeFrame
- Up to 6 weeks
- description
- Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMerzaai B, Tonnesen H, Rasmussen M, Lauridsen SV. Perioperative Alcohol and Smoking Cessation Intervention: Impact on Other Lifestyles. Semin Oncol Nurs. 2021 Feb;37(1):151116. doi: 10.1016/j.soncn.2020.151116. Epub 2021 Jan 6. PMID 33422365
- DERIVEDLauridsen SV, Thomsen T, Thind P, Tonnesen H. STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. Trials. 2017 Jul 17;18(1):329. doi: 10.1186/s13063-017-2065-6. PMID 28716147