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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Number of patients with postoperative complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cancelled operation
- •Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
- •Pregnant or breastfeeding women
- •Mentally incompetent patients
研究组 & 干预措施
Smoking and alcohol cessation education
干预措施: Educational programme for smoking and alcohol cessation (Behavioral)
Standard treatment
Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.
结局指标
主要结局
Number of patients with postoperative complications
时间窗: 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
次要结局
- Postoperative complications(up to 90 days)
- 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)
- Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation(Up to 12 months postoperatively)
研究者
Susanne Vahr lauridsen
MEd, PhD student
Rigshospitalet, Denmark