Stop Smoking in Spine Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Stop smoking.
- Кому может быть актуально
- Состояния в реестре: Smoking Cessation. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Influence of Stop Smoking to the Clinical and Radiological Outcome of Instrumented Neck and Back Surgery
Обзор
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.
Подробное описание
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).
Вмешательства
- Поведенческое Stop smoking
Sine fuma program is offered. nicotine is checked in urine
Первичные конечные точки
- ODI or NDI [Срок оценки: baseline, 2, 6 and 12 months post surgery]
Вторичные конечные точки (5)
- VAS leg or arm pain [Срок оценки: baseline, 2, 6 and 12 months post surgery]
- HADS [Срок оценки: baseline, 2, 6 and 12 months post surgery]
- EuroQol [Срок оценки: baseline, 2, 6 and 12 months post surgery]
- perceived recovery [Срок оценки: 2, 6 and 12 months post surgery]
- radiological evaluation for fusion [Срок оценки: 6 and 12 months after surgery]
Критерии участия
Критерии включения
- candidates for moderately complex instrumented surgery of the neck or low back.
Критерии исключения
- Patients undergoing surgery for malignancy or trauma are excluded.
- non Dutch speaking patients
- pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 1 центр
- Leiden University Medical Centre — Leiden
Идентификаторы
NCT: NCT06361459 · NL83858.058.12