Stop Smoking in Spine Surgery

Not Applicable

Recruiting

• Conditions: Smoking Cessation
• Interventions: Behavioral: Stop smoking

• Registration Number: NCT06361459
• Lead Sponsor: Leiden University Medical Center

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).

Study Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2024-01-04
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continues smoking	Stop smoking	will be planned for surgery and evaluated
Stop smoking	Stop smoking	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

Primary Outcome Measures

Name	Time	Method
ODI or NDI	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)

Secondary Outcome Measures

Name	Time	Method
VAS leg or arm pain	baseline, 2, 6 and 12 months post surgery	VAS leg (lumbar spine) or VAS arm pain (neck surgery),ranging from 0 mm (best) to 100 mm (worst)
EuroQol	baseline, 2, 6 and 12 months post surgery	quality of life, ranging from 0 (worst) to 1,0 (best)
perceived recovery	2, 6 and 12 months post surgery	perceived recovery in 7 grades ranging from 'completely recovered (= 1)' to 'much worse than I was before intervention (=7)'
HADS	baseline, 2, 6 and 12 months post surgery	Hospital Anxiety and Depression Scale, 2 scales ranging from 0 (best) to 18 (worst)
radiological evaluation for fusion	6 and 12 months after surgery	CT scan to evaluate speed of fusion

Trial Locations

Locations (1)

Leiden University Medical Centre; 🇳🇱 Leiden, Zuid Holland, Netherlands