Helping patients stop smoking before spine surgery
Official title: Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
Run by Leiden University Medical Center · NCT06361459 · Data updated 2026-11-12
This study is testing whether helping patients quit smoking before spine surgery can lead to better recovery and results compared to those who keep smoking or don’t smoke at all.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Status | Recruiting |
| Started | July 6, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 11, 2024 |
| Trial ID | NCT06361459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 who are scheduled for moderately complex instrumented surgery of the neck or low back.
✕Probably not a fit
Patients undergoing surgery for malignancy or trauma, as well as non-Dutch speaking individuals and pregnant women, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the impact of smoking cessation on the clinical and radiological outcomes of patients undergoing moderately complex instrumented spine surgery. It involves a multicenter observational cohort design, comparing outcomes between patients who quit smoking during the peri-operative period, those who continue to smoke, and a control group of non-smokers. Patients will be offered the SineFuma program to assist with quitting, and their progress will be monitored through various assessments over 12 months post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and outcomes for patients undergoing spine surgery who quit smoking.
How similar studies have gone: Other studies have shown positive outcomes related to smoking cessation in surgical populations, suggesting this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * candidates for moderately complex instrumented surgery of the neck or low back. Exclusion Criteria: * Patients undergoing surgery for malignancy or trauma are excluded. * non Dutch speaking patients * pregnancy
Where it's running
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Leiden University Medical Centre
Leiden, South Holland, Netherlands Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.