Stop Smoking in Spine Surgery

NCT06361459 | Recruiting DMC

• 1 other identifier: NL83858.058.12
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation, instrumented surgery, spondylodesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• VAS leg or arm pain

  baseline, 2, 6 and 12 months post surgery

• HADS

  baseline, 2, 6 and 12 months post surgery

• EuroQol

  baseline, 2, 6 and 12 months post surgery

• perceived recovery

  2, 6 and 12 months post surgery

• radiological evaluation for fusion

  6 and 12 months after surgery

Study Arms (3)

Stop smoking

EXPERIMENTAL

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

Behavioral: Stop smoking

Continues smoking

ACTIVE COMPARATOR

will be planned for surgery and evaluated

Behavioral: Stop smoking

Does not smoke

NO INTERVENTION

will be planned for surgery and evaluated

Interventions

Stop smoking BEHAVIORAL

Sine fuma program is offered. nicotine is checked in urine

Continues smoking; Stop smoking

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidates for moderately complex instrumented surgery of the neck or low back.

You may not qualify if:

• Patients undergoing surgery for malignancy or trauma are excluded.
• non Dutch speaking patients
• pregnancy

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Medical Center Haaglanden: collaborator
• Haga Hospital: collaborator
• Alrijne Hospital: collaborator
• Spaarne Gasthuis: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2300RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc PhD

Model Details: three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: April 11, 2024
• Study Start: July 6, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)