Not provided
Not provided
Not provided
Not provided
The study is being terminated prematurely due to insufficient participant recruitment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation. |
|
| Control group | No Intervention | Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive preoperative smoking cessation counselling | Behavioral | The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care. In brief, the intervention includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index (CCI) | The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints. | within a 90 days postoperative time period |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Days of hospital stay for planned surgery | perioperative |
| Costs of hospital stay | Costs of hospital stay for planned surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Fankhauser, PD Dr. med. | Klinik für Urologie, Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LUKS | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36038883 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Throughout the study patient data is collected in the electronic health record (LUKiS) in an uncoded manner. Allocation will be blinded. At the end of the study the LUKiS reporting team will generate a report, which will include all study data in a de-identified form. The analysis of the report with the pseudonymized data will be performed by the project statistician.
|
| perioperative |
| Readmission rate | Readmission rates for in-patient hospital stay after surgery | within a 90 days postoperative time period |
| Smoking abstinence | Number of patients who successfully quit smoking | within a one year postoperative time period |
| Smoking reduction | Decrease or increase of daily nicotine consumption | within a one year postoperative time period |
| Mental health | The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder. | one week preoperative |
| IMC/ICU admission | unplanned postoperative intermediate care or intensive care unit admission | perioperative |
| Transtheoretical Model | Stage of the Transtheoretical Model of behaviour change | preoperative |
| Quality of life Short Form Survey | The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state. | within a one year postoperative time period |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000074264 | Smoking Reduction |
| D009369 | Neoplasms |
| D011183 | Postoperative Complications |
| D012907 | Smoking |
| D014571 | Urologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided