Helping patients stop smoking before spine surgery
Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
NA · Leiden University Medical Center · NCT06361459
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06361459 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are scheduled for moderately complex instrumented surgery of the neck or low back.
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.
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 performed: Other studies have shown positive outcomes related to smoking cessation in surgical populations, suggesting this approach may be beneficial.
Eligibility criteria
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 this trial is running
Leiden, South Holland
- Leiden University Medical Centre — Leiden, South Holland, Netherlands (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoking Cessation, smoking cessation, instrumented surgery, spondylodesis