Preoperative Smoking Cessation in Patients Undergoing Surgery

Cancer Clinical Trial

— PORTICO  

Official title:

Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192837
• Other study ID #: 2021-8131
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2022
• Source: Luzerner Kantonsspital
• Contact: Studienkoordination Tumorzentrum
• Phone: 0041 41 205 59 64
• Email: studienkoordination.tumorzentrum[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 251
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cancer
• Cancer
• Gynecologic Cancer
• Head and Neck Cancer
• Perioperative Complication
• Postoperative Complications
• Smoking
• Smoking Cessation
• Smoking Reduction
• Surgery
• Surgery--Complications
• Thoracic Cancer
• Urologic Cancer
• Urologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	LUKS	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Length of hospital stay	Days of hospital stay for planned surgery	perioperative
Secondary	Costs of hospital stay	Costs of hospital stay for planned surgery	perioperative
Secondary	Readmission rate	Readmission rates for in-patient hospital stay after surgery	within a 90 days postoperative time period
Secondary	Smoking abstinence	Number of patients who successfully quit smoking	within a one year postoperative time period
Secondary	Smoking reduction	Decrease or increase of daily nicotine consumption	within a one year postoperative time period
Secondary	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
Secondary	IMC/ICU admission	unplanned postoperative intermediate care or intensive care unit admission	perioperative
Secondary	Transtheoretical Model	Stage of the Transtheoretical Model of behaviour change	preoperative
Secondary	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