Objective: To demonstrate that smoking cessation in the postoperative period has a positive impact on the clinical and radiological outcomes of instrumented spine surgery
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Oswestry Disability Index (lumbar spine) of de Neck Disability Index (neck)
Secondary outcome
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
The bony fusion will be assessed radiologically by CT at 6 and 12 months.
Background summary
Rationale: optimizing outcomes of instrumented neck and back surgery
Study objective
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
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 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 burden and risks
Stress: stop smoking with the help of the 'SineFuma stop smoking' program and
urine test for nicotine (for those 70 patients who indicate that they want to
stop smoking), for all 210 patients: complete a set of questionnaires 4 times.
Risks: No research-induced risks
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Patients eligible for instrumented spine surgery (cervical posterior
spondylodesis OR lumbar posterior spondylodesis) due to a degenerative cause.
Patients are between 18 and 75 years old
Patients master the Dutch language
Patients must be cleared for surgery by the anesthesiologist
To be eligible for the 'stop smoking' part, the patient must classify himself
as a 'smoker'
Exclusion criteria
Patients with malignancy
Patients with a fracture after trauma
Patients with high complex deformity
Pregnant women
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83858.058.23 |