Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

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 typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment210 (estimated)
SponsorLeiden University Medical Center
Academic / other
Locations1 site (Leiden, South Holland)
StatusRecruiting
StartedJuly 6, 2023
Main results expectedJune 30, 2026
Study endsDecember 31, 2026
Registry record updatedApril 11, 2024
Trial IDNCT06361459 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

  • Leiden University Medical Centre
    Leiden, South Holland, Netherlands
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.