Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diabetes or prediabetes présence
研究概览
简要总结
The purpose of the study is to assess, through systematic screening, the prevalence of diabetes or prediabetes in patients who are candidates for lumbar spine surgery.
详细描述
This is a prospective, longitudinal, single-center, open-label observational study on a population of patients undergoing lumbar spine surgery.
This study does not alter patient management or the physician-patient relationship. Assessments take place during routinely scheduled consultations. Fasting blood glucose and glycated hemoglobin measurements are part of the standard preoperative assessment. Patient self-administered questionnaires are routinely completed for practice evaluation purposes and constitute a database for routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients,
- •Patients who have been informed of the research and have not indicated their opposition to the use of their medical data,
- •Patients who are candidates for their first lumbar spine surgery, whether instrumented or not
排除标准
- •Non-instrumented percutaneous surgery (cementoplasty)
- •Presence of spinal osteosynthesis equipment
- •Surgery performed for an infectious or tumoral spinal condition
- •Surgery via an anterior or lateral approach
结局指标
主要结局
Diabetes or prediabetes présence
时间窗: Day 1
Diabetes is defined as a blood glucose level of at least 1.26 g/L and a glycated hemoglobin level greater than or equal to 6.5%. Prediabetes is defined as a blood glucose level greater than 1.10 g/L and less than 1.26 g/L and a glycated hemoglobin level between 5.7% and 6.4%.
次要结局
- Radicular pain(Month 3)
- Low back pain(Month 3)
- Functional Impact of the Disease(Month 3)