Stop Smoking in Spine Surgery

Smoking Cessation Clinical Trial

Official title:

Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361459
• Other study ID #: NL83858.058.12
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Particularly clinical outcome is evaluated, as well as radiological outcome.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Stop smoking
Sine fuma program is offered. nicotine is checked in urine

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	Zuid Holland

Sponsors (5)

Lead Sponsor	Collaborator
Leiden University Medical Center	Alrijne Hospital, Haga Hospital, Medical Center Haaglanden, Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

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