Chronic Subdural Hematoma, Chronic Subdural Hematomas
Conditions
Keywords
Chronic subdural hematoma, Burr-hole drainage, Enhanced recovery protocol
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Length-of-stay | Up to 6 months after surgery | — |
| Complication incidence | 30 days after surgery | Complications will be classified as medical complications (any nonsurgical complication occurring during the hospital stay after the surgery) and surgical complications. Medical complications are considered minor if complete recovery is to be expected (eg, electrolyte disturbances or urinary tract infection) and major in case of potential serious consequences and partial or no recovery (eg, stroke, severe pneumonia, or pulmonary embolism). Surgical complications are defined as every complication directly related to the surgery. Epileptic seizures in the postoperative period will be considered separately. |
| Mortality | 30 days after surgery | 30-day mortality |
| 5-level EQ-5D (EQ-5D-5L) | 6 months after surgery | The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive systems score ranges from 5 to 25, with a higher score meaning worse health. De EQ VAS is scored from 0 to 100, with a higher score meaning better self-rated health. |
| modified Rankin Scale (mRS) | 6 months after surgery | Scale measuring degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms at all) to 5 (dead). |
Countries
Belgium
Contacts
CONTACTSiebe Orolé, Medical degree
PRINCIPAL_INVESTIGATORThomas Decramer, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Outcome results
None listed