Clinical trial NCT05192837: Preoperative Smoking Cessation in Patients Undergoing Surgery
Official title: Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Smoking Reduction
Surgery--Complications
Surgery
Cancer
Postoperative Complications
Perioperative Complication
Smoking
Abdominal Cancer
Thoracic Cancer
Urologic Cancer
Gynecologic Cancer
Head and Neck Cancer
Keywords: preoperative smoking cessation
intensive smoking cessation
intermediate-risk surgery
high-risk surgery
nicotine replacement therapy
varenicline
bupropion
clavien dindo classification
comprehensive complication index
epic
electronic health record
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised in a 1:1 ratio to either the intervention or control group using service of the University of Graz (www.randomizer.at). Before randomisation patients will be pre-stratified for age (≤60, \>60 years) and procedure (intermediate versus high-risk procedures). Both factors have been identified in a previous retrospective cohort study at our institution as risk factors for complications. For that reason, minimization, as an efficient way to control for confounding in small to moderately sized trials, will be used. Also, minimization automatically ensures concealment of random allocation since there is no pre-existing randomization list.
Primary purpose: PREVENTION

Brief summary: Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Patient listed for intermediate or high-risk surgery at the Kantonsspital of Lucerne
* Patient undergoing surgery in one of the following departments: Abdominal surgery, thoracic surgery, cardiac surgery, urology, gynaecology, vascular surgery or head and neck surgery
* Date of surgery \>2 weeks after date of listing for surgery or discussion by tumor board
* Current smokers, defined as daily smoking of at least one cigarette, cigar or pipe
* Age over 18 years
* Able to give signed written informed consent

Exclusion Criteria:

* Plastic surgery
* Consumption of illegal drugs
* Alcohol dependency defined as preexisting alcohol related disorders (eg. alcoholic psychosis, Alcohol abuse, Alcohol polyneuropathy, degeneration of nervous system due to alcohol, Alcoholic myopathy, Alcoholic liver disease)
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia

Primary outcomes:
measure: Comprehensive Complication Index (CCI)
timeFrame: within a 90 days postoperative time period
Secondary outcomes:
measure: Length of hospital stay
timeFrame: perioperative
measure: Costs of hospital stay
timeFrame: perioperative
measure: Readmission rate
timeFrame: within a 90 days postoperative time period
measure: Smoking abstinence
timeFrame: within a one year postoperative time period
measure: Smoking reduction
timeFrame: within a one year postoperative time period
measure: Mental health
timeFrame: one week preoperative
measure: IMC/ICU admission
timeFrame: perioperative
measure: Transtheoretical Model
timeFrame: preoperative
measure: Quality of life Short Form Survey
timeFrame: within a one year postoperative time period
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: LUKS
Study officials:
affiliation: Klinik für Urologie, Luzerner Kantonsspital
name: Christian Fankhauser, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fankhauser CD, Affentranger A, Cortonesi B, Jeker U, Gass M, Minervini F, Jung G, Christmann C, Brambs C, Puhan MA, Held U. Preoperative smoking cessation program in patients undergoing intermediate to high-risk surgery: a randomized, single-blinded, controlled, superiority trial. Trials. 2022 Aug 29;23(1):717. doi: 10.1186/s13063-022-06628-8.