Smoking CessationNCT06361459
Stop Smoking in Spine Surgery
A study testing Stop smoking in people with Smoking Cessation, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Stop smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidates for moderately complex instrumented surgery of the neck or low back.
Who cannot join
- Patients undergoing surgery for malignancy or trauma are excluded.
- non Dutch speaking patients
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, South Holland, 2300RC
carmen vleggeert-lankamp, MD MSc PhD, +31630925428, cvleggeert@lumc.nl
About this study
Official title: Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome.
Read the detailed description
Rationale: Optimizing outcomes of instrumented neck and back surgery Objective: To demonstrate that smoking cessation in the postoperative period has a positive impact on the clinical and radiological outcomes of instrumented spine surgery Study design: This is a multicenter observational cohort study with three groups of patients indicated to undergo moderately complex instrumented spinal surgery: a group of patients who continue to smoke is compared with a group who stop smoking in the peri-operative period of time. In addition, the results of a group of patients who do not smoke are recorded. Follow-up moments are baseline, 2, 6 and 12 months after surgery.
Study population: Patients between 18 and 75 years of age, who are candidates for moderately complex instrumented surgery of the neck or low back. Patients undergoing surgery for malignancy or trauma are excluded.
Intervention: If patients indicate that they are open to quitting smoking, they will be offered the SineFuma program. After 4 weeks, testing of nicotine in the urine will check whether smoking has actually stopped.
Study parameters: Primary outcome measure is the Oswestry Disability Index (low back) or the Neck Disability Index (neck). Furthermore, the VAS leg pain (or arm pain) and VAS back pain (or neck pain), the Hospital Anxiety and Depression Scale, the EuroQol and the patient's perceived recovery will be evaluated. The bony fusion will be assessed radiologically by CT at 6 and 12 months.
This is a multicenter observational cohort study adjusted for age and ASA score.
Evaluation moments: Patients will be asked to complete questionnaires at baseline and 2, 6 and 12 months after surgery. Patients who indicate that they have stopped smoking will be asked to submit a urine sample. For smokers who have to quit first, there is a second baseline measurement at the time they are scheduled for surgery. Data will be collected per center and brought together in the Data Coordination Center in Leiden (LUMC).
- Conditions
- Smoking Cessation
- Being tested
- Stop smoking
- Keywords
- smoking cessation, instrumented surgery, spondylodesis
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop smokingBehavioural
Sine fuma program is offered. nicotine is checked in urine
| Study group | Role | What they receive |
|---|---|---|
| Stop smoking | Experimental | patients are stimulated to stop smoking, using the Sine Fuma program. after 4 weeks nicotine in urine will be tested. if stopped: planned for surgery. 4 weeks after surgery nicotine in urine is checked again. will be planned for surgery and evaluated Receives: Behavioral: Stop smoking |
| Continues smoking | Active comparator | will be planned for surgery and evaluated Receives: Behavioral: Stop smoking |
| Does not smoke | No intervention | will be planned for surgery and evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI or NDI
Oswestry Disability Index (lumbar spine) or Neck Disability Index (neck surgery), ranging from 0 (best) to 100 (worst)
Measured: baseline, 2, 6 and 12 months post surgery
Secondary outcomes (5)
VAS leg or arm pain
VAS leg (lumbar spine) or VAS arm pain (neck surgery),ranging from 0 mm (best) to 100 mm (worst)
Measured: baseline, 2, 6 and 12 months post surgery
HADS
Hospital Anxiety and Depression Scale, 2 scales ranging from 0 (best) to 18 (worst)
Measured: baseline, 2, 6 and 12 months post surgery
EuroQol
quality of life, ranging from 0 (worst) to 1,0 (best)
Measured: baseline, 2, 6 and 12 months post surgery
perceived recovery
perceived recovery in 7 grades ranging from 'completely recovered (= 1)' to 'much worse than I was before intervention (=7)'
Measured: 2, 6 and 12 months post surgery
radiological evaluation for fusion
CT scan to evaluate speed of fusion
Measured: 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start6 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Haga Hospital, Alrijne Hospital, Spaarne Gasthuis
- Responsible party
- Principal investigator, C.L.A.Vleggeert-Lankamp, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361459
- Sponsor's protocol ID
- NL83858.058.12
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
- ClinicalTrials.gov ID
- NCT06361459
- Acronym / sponsor ID
- NL83858.058.12
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, instrumented surgery, spondylodesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Haga Hospital, Alrijne Hospital, Spaarne Gasthuis
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 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.
Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome.
Detailed description
Rationale: Optimizing outcomes of instrumented neck and back surgery Objective: To demonstrate that smoking cessation in the postoperative period has a positive impact on the clinical and radiological outcomes of instrumented spine surgery Study design: This is a multicenter observational cohort study with three groups of patients indicated to undergo moderately complex instrumented spinal surgery: a group of patients who continue to smoke is compared with a group who stop smoking in the peri-operative period of time. In addition, the results of a group of patients who do not smoke are recorded. Follow-up moments are baseline, 2, 6 and 12 months after surgery.
Study population: Patients between 18 and 75 years of age, who are candidates for moderately complex instrumented surgery of the neck or low back. Patients undergoing surgery for malignancy or trauma are excluded.
Intervention: If patients indicate that they are open to quitting smoking, they will be offered the SineFuma program. After 4 weeks, testing of nicotine in the urine will check whether smoking has actually stopped.
Study parameters: Primary outcome measure is the Oswestry Disability Index (low back) or the Neck Disability Index (neck). Furthermore, the VAS leg pain (or arm pain) and VAS back pain (or neck pain), the Hospital Anxiety and Depression Scale, the EuroQol and the patient's perceived recovery will be evaluated. The bony fusion will be assessed radiologically by CT at 6 and 12 months.
This is a multicenter observational cohort study adjusted for age and ASA score.
Evaluation moments: Patients will be asked to complete questionnaires at baseline and 2, 6 and 12 months after surgery. Patients who indicate that they have stopped smoking will be asked to submit a urine sample. For smokers who have to quit first, there is a second baseline measurement at the time they are scheduled for surgery. Data will be collected per center and brought together in the Data Coordination Center in Leiden (LUMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop
| Arm | Type | Receives |
|---|---|---|
| Stop smoking | Experimental | Behavioral: Stop smokingpatients are stimulated to stop smoking, using the Sine Fuma program. after 4 weeks nicotine in urine will be tested. if stopped: planned for surgery. 4 weeks after surgery nicotine in urine is checked again. will be planned for surgery and evaluated |
| Continues smoking | Active comparator | Behavioral: Stop smokingwill be planned for surgery and evaluated |
| Does not smoke | No intervention | –will be planned for surgery and evaluated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- candidates for moderately complex instrumented surgery of the neck or low back.
Key exclusion criteria (3 listed)
- Patients undergoing surgery for malignancy or trauma are excluded.
- non Dutch speaking patients
- pregnancy
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 |
|---|---|---|
| Stop smokingSine fuma program is offered. nicotine is checked in urine | Behavioural | Continues smoking, Stop smoking |
Primary outcome
ODI or NDI
Time frame: baseline, 2, 6 and 12 months post surgery
Oswestry Disability Index (lumbar spine) or Neck Disability Index (neck surgery), ranging from 0 (best) to 100 (worst)
5 secondary outcomes
VAS leg or arm pain
Time frame: baseline, 2, 6 and 12 months post surgery
HADS
Time frame: baseline, 2, 6 and 12 months post surgery
EuroQol
Time frame: baseline, 2, 6 and 12 months post surgery
perceived recovery
Time frame: 2, 6 and 12 months post surgery
radiological evaluation for fusion
Time frame: 6 and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop smoking in people with Smoking Cessation, run by Leiden University Medical Center at 1 site in Netherlands.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Apr 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI or NDI (time frame: baseline, 2, 6 and 12 months post surgery). 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 11 Apr 2024.