Enhanced Recovery Pathway for Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Existence of a chronic subdural hematoma requiring burr-hole drainage
- •Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
排除标准
- •Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor)
- •History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH
研究组 & 干预措施
ERP-cohort
Cohort of patients treated after ERP-implementation, prospective data collection
Pre-ERP-cohort
Patients treated before ERP-implementation, retrospective identified
结局指标
主要结局
Recurrence rate
时间窗: 6 months after surgery
Recurrence is defined as persistent deficits, clinical deterioration or radiographic hematoma enlargement requiring ipsilateral re-intervention (surgical or by means of middle meningeal artery embolization), assessed until 6 months after index surgery.
次要结局
- Length-of-stay(Up to 6 months after surgery)
- Complication incidence(30 days after surgery)
- Mortality(30 days after surgery)
- 5-level EQ-5D (EQ-5D-5L)(6 months after surgery)
- modified Rankin Scale (mRS)(6 months after surgery)
研究者
Siebe Orolé
Neurosurgical trainee
Universitaire Ziekenhuizen KU Leuven