Preoperative Smoking Cessation in Patients Undergoing Surgery (PORTICO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Smoking Cessation; Postoperative Complications; Cancer; Head and Neck Cancer; Gynecologic Cancer; Smoking Reduction; Surgery; Surgery--Complications; Thoracic Cancer; Abdominal Cancer; Urologic Cancer; Perioperative Complication
• Intervention / Treatment: Behavioral: Intensive preoperative smoking cessation counselling

• Study Type: Interventional
• Enrollment (Anticipated): 251
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Studienkoordination Tumorzentrum; Phone Number: 0041 41 205 59 64; Email: studienkoordination.tumorzentrum@luks.ch

Study Locations

• Switzerland
  • Luzern, Switzerland, 6000
    • Recruiting
    • LUKS

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: January 1, 2022
• First Submitted That Met QC Criteria: January 1, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: nicotine replacement therapy; varenicline; bupropion; high-risk surgery; electronic health record; preoperative smoking cessation; intensive smoking cessation; intermediate-risk surgery; clavien dindo classification; comprehensive complication index; epic
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Postoperative Complications; Urologic Neoplasms
• Other Study ID Numbers: 2021-8131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No