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临床试验/NCT01260233
NCT01260233已完成不适用

The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
2
主要终点
smoking cessation

研究概览

简要总结

The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.

详细描述

Previous studies have shown that patients have up to one-third fewer complications after surgery when they quit smoking at least several weeks before surgery. Nicotine replacement therapy (which relieves cravings for cigarettes) and support by healthcare professionals have been shown to help patients quit smoking, particularly when encountering a major health event (e.g. surgery). In addition, quitting smoking in preparation for surgery sometimes results in quitting for a longer period of time after surgery, giving these patients the health benefits of long-term smoking cessation such as reduced rates of cancer and heart disease.

The preadmission clinic at St. Joseph's Health Care, London, Ontario, is assessing how effective a new 'Stop Smoking' program is for patients preparing for surgery. The program will include brief counselling in the clinic, smoking cessation brochures, six weeks of free transdermal nicotine replacement therapy and a referral to the Canadian Cancer Society's Smokers' Helpline telephone advice line. Patients that are smokers and preparing for their elective surgery will be invited to join the study, then be assigned to a group that either participates in the program or not. These groups will then be compared in terms of success at quitting smoking and complication rates around the time of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • smokers (defined as those that smoke at least 2 cigarettes per day and have smoked within the last 7 days)
  • over age 18
  • presenting to preadmission clinic at St. Joseph's Health Care at least 3 weeks prior to scheduled date of surgery

排除标准

  • less than age 18
  • poor proficiency in English language
  • breastfeeding
  • unable to consent due to severe mental illness or dementia
  • actively participating in another smoking cessation trial

结局指标

主要结局

smoking cessation

时间窗: date of surgery

Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.

次要结局

  • smoking cessation/reduction(day of surgery)
  • Intraoperative complications and immediate post-operative complications(day of surgery)
  • Time until PACU readiness for discharge / actual time in PACU(day of surgery)
  • Unanticipated hospital admission(day of surgery)
  • Hospital length of stay(until hospital discharge)
  • Smoking cessation at 12 months(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Jones

Associate Professor

Lawson Health Research Institute

研究点 (2)

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