Stop Smoking in Spine Surgery

L

Leiden University Medical Center (LUMC)

Status

Enrolling

Conditions

Smoking Cessation

Treatments

Behavioral: Stop smoking

Study type

Interventional

Funder types

Other

Identifiers

NCT06361459
NL83858.058.12

Details and patient eligibility

About

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.

Full 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).

Enrollment

210 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

210 participants in 3 patient groups

Stop smoking
Experimental group
Description:
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
Treatment:
Behavioral: Stop smoking
Continues smoking
Active Comparator group
Description:
will be planned for surgery and evaluated
Treatment:
Behavioral: Stop smoking
Does not smoke
No Intervention group
Description:
will be planned for surgery and evaluated

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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