Preoperative Smoking Cessation in Patients Undergoing Surgery (PORTICO)

• ClinicalTrials.gov Identifier: NCT05192837
• Recruitment Status: Recruiting
• First Posted: January 14, 2022
• Last Update Posted: August 18, 2022
• Sponsor: Luzerner Kantonsspital
• Information provided by (Responsible Party): Christian Fankhauser, Luzerner Kantonsspital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Behavioral: Intensive preoperative smoking cessation counselling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial
• Actual Study Start Date: April 1, 2022
• Estimated Primary Completion Date: September 30, 2024
• Estimated Study Completion Date: September 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; 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.	Behavioral: Intensive preoperative smoking cessation counselling; 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: Informative content about advantages of smoking cessation; Scheduling service for a motivational interview by a TSS in office to implement a treatment plan; For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery; Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis; TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients
No Intervention: Control group; 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.

Outcome Measures

Primary Outcome Measures :

1. Comprehensive Complication Index (CCI) [ Time Frame: within a 90 days postoperative time period ]
   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.

Secondary Outcome Measures :

1. Length of hospital stay [ Time Frame: perioperative ]
   Days of hospital stay for planned surgery
2. Costs of hospital stay [ Time Frame: perioperative ]
   Costs of hospital stay for planned surgery
3. Readmission rate [ Time Frame: within a 90 days postoperative time period ]
   Readmission rates for in-patient hospital stay after surgery
4. Smoking abstinence [ Time Frame: within a one year postoperative time period ]
   Number of patients who successfully quit smoking
5. Smoking reduction [ Time Frame: within a one year postoperative time period ]
   Decrease or increase of daily nicotine consumption
6. Mental health [ Time Frame: one week preoperative ]
   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.
7. IMC/ICU admission [ Time Frame: perioperative ]
   unplanned postoperative intermediate care or intensive care unit admission
8. Transtheoretical Model [ Time Frame: preoperative ]
   Stage of the Transtheoretical Model of behaviour change
9. Quality of life Short Form Survey [ Time Frame: within a one year postoperative time period ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patient listed for intermediate or high-risk surgery (Appendix 2) [20] at the Kantonsspital of Lucerne
• Patient undergoing surgery in one of the following departments: Abdominal surgery, thoracic surgery, urology, gynaecology, vascular surgery or head and neck surgery
• Date of surgery >4 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

Contacts and Locations

Contacts

Contact: Studienkoordination Tumorzentrum; 0041 41 205 59 64; studienkoordination.tumorzentrum@luks.ch

Locations

Switzerland

LUKS; Recruiting

Luzern, Switzerland, 6000

Sponsors and Collaborators

Luzerner Kantonsspital

Investigators

• Principal Investigator: Christian Fankhauser, PD Dr. med.; Klinik für Urologie, Luzerner Kantonsspital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Christian Fankhauser, Principal Investigator, Luzerner Kantonsspital
• ClinicalTrials.gov Identifier: NCT05192837
• Other Study ID Numbers: 2021-8131
• First Posted: January 14, 2022
• Last Update Posted: August 18, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Fankhauser, Luzerner Kantonsspital:

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

Additional relevant MeSH terms:

Urologic Neoplasms; Postoperative Complications; Neoplasms by Site; Neoplasms; Pathologic Processes; Urogenital Neoplasms