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To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation (TOSCAN)
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Purpose
Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.
The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.
The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.
| Condition | Intervention |
|---|---|
| Chronic Subdural Hematoma | Other: cranial CT scan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Diagnostic |
| Official Title: | To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlled Trial |
- modified Rankin Scale [ Time Frame: 6 months ]
- Rate of reoperation [ Time Frame: 6 months ]
- Mini Mental Status [ Time Frame: 6 months ]
- NIHSS [ Time Frame: 6 months ]
- QLQ-C30 [ Time Frame: 6 months ]
- Total length of hospitalisation [ Time Frame: 6 months ]
- Influence of the size and radiological features of the hematoma on rate of recurrence [ Time Frame: 6 months ]
| Enrollment: | 368 |
| Actual Study Start Date: | June 1, 2012 |
| Study Completion Date: | February 6, 2017 |
| Primary Completion Date: | February 6, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
|
Other: cranial CT scan
Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
|
|
No Intervention: 2
Patients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours
- Age 18 years or older
- Written informed consent from the patient to participate in the study
Exclusion Criteria
- Moribund state of health prohibiting surgery
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Recurrent hematoma if the first surgery was performed before study start
- CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa
- Pregnancy
- Patient with Metastatic Disease and a high possibility to pass away in the next 6 month
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01624545
| Switzerland | |
| Department of Neurosurgery | |
| Bern, Switzerland, 3010 | |
| Principal Investigator: | Philippe E Schucht, MD | Inselspital Bern, University Bern |
More Information
Publications:
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT01624545 History of Changes |
| Other Study ID Numbers: |
218/10 2179 |
| Study First Received: | June 18, 2012 |
| Last Updated: | February 10, 2017 |
Keywords provided by University Hospital Inselspital, Berne:
|
chronic subdural hematoma burr hole trepanation radiologic follow-up outcome recurrence |
Additional relevant MeSH terms:
|
Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Pathologic Processes Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Vascular Diseases Cardiovascular Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on July 26, 2017