Clinical trial NCT06361459: Stop Smoking in Spine Surgery
Official title: Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation, instrumented surgery, spondylodesis
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Center Haaglanden
name: Haga Hospital
name: Alrijne Hospital
name: Spaarne Gasthuis
First posted: 2024-04-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility 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

Primary outcomes:
measure: ODI or NDI
timeFrame: baseline, 2, 6 and 12 months post surgery
Secondary outcomes:
measure: VAS leg or arm pain
timeFrame: baseline, 2, 6 and 12 months post surgery
measure: HADS
timeFrame: baseline, 2, 6 and 12 months post surgery
measure: EuroQol
timeFrame: baseline, 2, 6 and 12 months post surgery
measure: perceived recovery
timeFrame: 2, 6 and 12 months post surgery
measure: radiological evaluation for fusion
timeFrame: 6 and 12 months after surgery
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid Holland
Study officials:
References: