Postoperative Balloninflation After Evacuation of cSDH

Study Overview
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Brief Summary
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In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver (Valsalva maneuver) every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.

Official Title
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Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Balloninflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years surgically treated cSDH patients with an operatively implanted subdural drainage Exclusion Criteria: age under 18 years Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours conservative treatment of cSDH patients without an operatively implanted subdural drainage patient cannot be consented participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloninflation Group<br>Patient who will perform a balloninflation after operation | Procedure: Balloninflation<br>* Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.<br>|
| Sham Comparator: Conservative Group<br>Patient without performing a balloninflation | Procedure: Balloninflation<br>* Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate | Reoperation of chronic subdural hematoma | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Functional Outcome | Modified Rankin Scale (0-6) 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. mRS0-3: favorable Outcome mRS: 4-6: unfavorable Outcome | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence rate of cSDH, Outcome