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| Name | Class |
|---|---|
| Frederiksberg University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
| Odense University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking and alcohol cessation education | Experimental |
| |
| Standard treatment | No Intervention | Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational programme for smoking and alcohol cessation | Behavioral | 5 meetings within 6 weeks containing education and pharmacologic support |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | up to 90 days | |
| Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation | Up to 12 months postoperatively | |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Tønnesen, Professor | WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Hospital of Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33422365 | Derived | Merzaai 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. | |
| 28716147 | Derived | Lauridsen 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. |
| Label | URL |
|---|---|
| DaBlaCa study number 6 | View source |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D012907 | Smoking |
| D000428 | Alcohol Drinking |
| D016540 | Smoking Cessation |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| OTHER |
| Aarhus University Hospital | OTHER |
| Karolinska Institutet | OTHER |
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|
| Length of stay |
| From day of surgery to day of discharge |
| Time to return to work or habitual level of activity | Up to 12 months |
| Mortality | Up to 12 months postoperatively |
| Quality of life ( EORTC QLQ BLM 30 and EQ5D) | Up to 12 months postoperatively |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
| D015438 | Health Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |