Enhanced Recovery Pathway for Chronic Subdural Hematoma
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Recurrence rate
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
ERP-cohort
Cohort of patients treated after ERP-implementation, prospective data collection
Pre-ERP-cohort
Patients treated before ERP-implementation, retrospective identified
Outcomes
Primary Outcomes
Recurrence rate
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Siebe Orolé
Neurosurgical trainee
Universitaire Ziekenhuizen KU Leuven