Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361459
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-04
Brief Title:
Stop Smoking in Spine Surgery
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None