Smoking CessationNCT06663020
Impact of Smoking Cessation Duration on Postoperative Complications in Lung Cancer Surgery
An observational study of Smoking Cessation and Lung Cancer (NSCLC), run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between the duration of smoking cessation before surgery and postoperative complications in lung cancer patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoking Cessation, Lung Cancer (NSCLC), Postoperative Complication
- What is being tested?
- Smoking Cessation Duration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from patients diagnosed with non-small cell lung cancer at the Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery. The study population consists of individuals scheduled for elective lung cancer surgery under general anesthesia, reflecting a clinical sample of patients who are typically managed within a tertiary care hospital setting.
Who may be able to join
- Patients aged between 18 and 80 years.
- Patients scheduled for elective surgery under general anesthesia due to NSCL.
- Patients classified as American Society of Anesthesiologists (ASA) I-III.
- Patients or their legally authorized representatives who have provided informed consent.
Who cannot join
- Patients with advanced chronic obstructive pulmonary disease (COPD) classified as GOLD Grade III-IV.
- Patients with severe and uncontrolled bronchial asthma.
- Patients with severe neuromuscular diseases or advanced thoracic deformity.
- Patients with severe heart disease classified as New York Heart Association (NYHA) Class III-IV.
- Patients with cognitive impairments.
- Patients undergoing emergency surgery.
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- Pregnant patients.
- Patients with coagulopathy.
- Patients who have previously undergone video-assisted thoracoscopic surgery (VATS) and/or thoracotomy.
- Patients who died perioperatively.
- Patients or their legally authorized representatives who did not provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
Samsun, Samsun, 55139
About this study
This study aims to investigate the relationship between the duration of smoking cessation before surgery and postoperative complications in lung cancer patients undergoing surgery. Lung cancer surgery patients who have recently quit smoking or are long-term nonsmokers will be evaluated to determine if the timing of smoking cessation impacts the risk of complications after surgery. By analyzing these factors, the study seeks to provide guidance on optimal smoking cessation timing to reduce postoperative risks.
Read the detailed description
This prospective observational study aims to examine the impact of smoking cessation duration on postoperative complications in lung cancer surgery patients. Lung cancer remains the most lethal type of cancer globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. Tobacco use is the most well-established risk factor for lung cancer, and a significant portion of lung cancer patients have either smoked in the past or continue to smoke. Smoking status and the timing of cessation before surgery have been shown to influence postoperative outcomes. Prior research suggests that cessation at least 2-4 weeks before surgery may reduce postoperative complications, with the World Health Organization recommending a minimum of four weeks of cessation before surgery to decrease the risk of adverse outcomes.
In this study, patients will not be categorized based on smoking or cessation status alone but will be documented on a continuum by recording the exact number of days or weeks between their smoking cessation and their surgical procedure. The primary objective is to assess whether a specific duration of smoking cessation is associated with a reduced risk of postoperative complications, including both pulmonary and non-pulmonary complications. These complications are defined in two categories: respiratory (e.g., atelectasis, pneumonia, respiratory failure) and non-respiratory (e.g., atrial fibrillation, myocardial infarction, wound infection).
Patients with advanced chronic obstructive pulmonary disease (COPD), uncontrolled asthma, severe neuromuscular disease, advanced thoracic deformity, or severe cardiovascular disease will be excluded to minimize confounding variables. The study will also exclude patients with emergency surgeries, pregnant individuals, and those who have undergone prior thoracic surgeries.
The sample size calculation, performed using G*Power software, determined a minimum of 248 participants would be needed to achieve a 95% confidence level and statistical power of 95%. Data analysis will include logistic regression to examine the relationship between smoking cessation duration and the occurrence of postoperative complications. Risk assessment tools, including the ARISCAT, Gupta Postoperative Pneumonia Risk, and Melbourne Group Scale, will be utilized to evaluate each patient's risk profile.
Data collection will focus on the following variables:
Patient demographics, comorbidities, neoadjuvant therapy, preoperative smoking history, lung function tests, operative and anesthesia times, intraoperative blood loss, pathological staging, and 30-day postoperative complications.
Quality assurance will involve source data verification from medical records to ensure accuracy, as well as routine data validation checks to maintain data consistency.
The statistical analysis will be guided by a comprehensive analysis plan, detailing the primary and secondary outcome evaluations. The findings aim to contribute to understanding the optimal smoking cessation timing to reduce surgical risks and enhance patient outcomes in lung cancer surgery.
- Being tested
- Smoking Cessation Duration
- Keywords
- lung cancer, smoking cessation, postoperative complication, thoracic surgery
- Medical subject headings
- Smoking Cessation, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation DurationBehavioural
Participants are categorized based on their smoking status and the duration since they quit smoking prior to lung cancer surgery. This observational study focuses on evaluating the relationship between the duration of smoking cessation (measured in days or weeks) and the incidence of postoperative complications. Smoking cessation duration is recorded for each participant to determine its impact on surgical outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Complications Among Patients Following Lung Cancer Surgery Based on Duration of Smoking Cessation
Postoperative complications will be assessed in patients who have undergone lung cancer surgery. Complications include both pulmonary (e.g., pneumonia, atelectasis, prolonged air leak) and non-pulmonary events (e.g., atrial fibrillation, wound infection) occurring within 30 days after surgery. The duration of smoking cessation prior to surgery will be recorded for each patient, and complications will be documented according to standard clinical criteria. This measure aims to determine if the length of smoking cessation impacts the likelihood and type of postoperative complications.
Measured: From the day of surgery to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Jun 2023
- Primary completion15 Nov 2024
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663020
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/19
- Status last verified
- Dec 2024
- First submitted
- 27 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoking Cessation Duration on Postoperative Complications in Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT06663020
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/19
- Keywords
- lung cancer, smoking cessation, postoperative complication, thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the relationship between the duration of smoking cessation before surgery and postoperative complications in lung cancer patients undergoing surgery. Lung cancer surgery patients who have recently quit smoking or are long-term nonsmokers will be evaluated to determine if the timing of smoking cessation impacts the risk of complications after surgery. By analyzing these factors, the study seeks to provide guidance on optimal smoking cessation timing to reduce postoperative risks.
Detailed description
This prospective observational study aims to examine the impact of smoking cessation duration on postoperative complications in lung cancer surgery patients. Lung cancer remains the most lethal type of cancer globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. Tobacco use is the most well-established risk factor for lung cancer, and a significant portion of lung cancer patients have either smoked in the past or continue to smoke. Smoking status and the timing of cessation before surgery have been shown to influence postoperative outcomes. Prior research suggests that cessation at least 2-4 weeks before surgery may reduce postoperative complications, with the World Health Organization recommending a minimum of four weeks of cessation before surgery to decrease the risk of adverse outcomes.
In this study, patients will not be categorized based on smoking or cessation status alone but will be documented on a continuum by recording the exact number of days or weeks between their smoking cessation and their surgical procedure. The primary objective is to assess whether a specific duration of smoking cessation is associated with a reduced risk of postoperative complications, including both pulmonary and non-pulmonary complications. These complications are defined in two categories: respiratory (e.g., atelectasis, pneumonia, respiratory failure) and non-respiratory (e.g., atrial fibrillation, myocardial infarction, wound infection).
Patients with advanced chronic obstructive pulmonary disease (COPD), uncontrolled asthma, severe neuromuscular disease, advanced thoracic deformity, or severe cardiovascular disease will be excluded to minimize confounding variables. The study will also exclude patients with emergency surgeries, pregnant individuals, and those who have undergone prior thoracic surgeries.
The sample size calculation, performed using G*Power software, determined a minimum of 248 participants would be needed to achieve a 95% confidence level and statistical power of 95%. Data analysis will include logistic regression to examine the relationship between smoking cessation duration and the occurrence of postoperative complications. Risk assessment tools, including the ARISCAT, Gupta Postoperative Pneumonia Risk, and Melbourne Group Scale, will be utilized to evaluate each patient's risk profile.
Data collection will focus on the following variables:
Patient demographics, comorbidities, neoadjuvant therapy, preoperative smoking history, lung function tests, operative and anesthesia times, intraoperative blood loss, pathological staging, and 30-day postoperative complications.
Quality assurance will involve source data verification from medical records to ensure accuracy, as well as routine data validation checks to maintain data consistency.
The statistical analysis will be guided by a comprehensive analysis plan, detailing the primary and secondary outcome evaluations. The findings aim to contribute to understanding the optimal smoking cessation timing to reduce surgical risks and enhance patient outcomes in lung cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from patients diagnosed with non-small cell lung cancer at the Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery. The study population consists of individuals scheduled for elective lung cancer surgery under general anesthesia, reflecting a clinical sample of patients who are typically managed within a tertiary care hospital setting.
Key inclusion criteria (4 listed)
- Patients aged between 18 and 80 years.
- Patients scheduled for elective surgery under general anesthesia due to NSCL.
- Patients classified as American Society of Anesthesiologists (ASA) I-III.
- Patients or their legally authorized representatives who have provided informed consent.
Key exclusion criteria (11 listed)
- Patients with advanced chronic obstructive pulmonary disease (COPD) classified as GOLD Grade III-IV.
- Patients with severe and uncontrolled bronchial asthma.
- Patients with severe neuromuscular diseases or advanced thoracic deformity.
- Patients with severe heart disease classified as New York Heart Association (NYHA) Class III-IV.
- Patients with cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation DurationParticipants are categorized based on their smoking status and the duration since they quit smoking prior to lung cancer surgery. This observational study focuses on evaluating the relationship between the duration of smoking cessation (measured in days or weeks) and the incidence of postoperative complications. Smoking cessation duration is recorded for each participant to determine its impact on surgical outcomes. | Behavioural | – |
Primary outcome
Incidence of Postoperative Complications Among Patients Following Lung Cancer Surgery Based on Duration of Smoking Cessation
Time frame: From the day of surgery to 30 days postoperatively
Postoperative complications will be assessed in patients who have undergone lung cancer surgery. Complications include both pulmonary (e.g., pneumonia, atelectasis, prolonged air leak) and non-pulmonary events (e.g., atrial fibrillation, wound infection) occurring within 30 days after surgery. The duration of smoking cessation prior to surgery will be recorded for each patient, and complications will be documented according to standard clinical criteria. This measure aims to determine if the length of smoking cessation impacts the likelihood and type of postoperative complications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Lung Cancer (NSCLC), run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Complications Among Patients Following Lung Cancer Surgery Based on Duration of Smoking Cessation (time frame: From the day of surgery to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.