Irrigation of Chronic Subdural Hematomas - is More Better?

Study Overview
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Brief Summary
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There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered. Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.

Official Title
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Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies

Conditions
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Hematoma, Subdural, Chronic

Intervention / Treatment
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* Procedure: Burr hole surgery with various drainage techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005). Exclusion Criteria: Chronic subdural hematoma in arachnoid cyst(s) Previous CSDH surgery External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles) CSDH due to previous intracranial surgery (within 6 months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trondheim<br>Burr hole surgery with passive subdural drainage | Procedure: Burr hole surgery with various drainage techniques<br>* Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain<br>|
| Tromsø<br>Burr hole surgery with continuous irrigation | Procedure: Burr hole surgery with various drainage techniques<br>* Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain<br>|
| Stockholm<br>Burr hole surgery with active subgaleal drainage | Procedure: Burr hole surgery with various drainage techniques<br>* Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reoperations | Number of reoperations (X/N, %) between centers | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous irrigation versus other drainage | Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska) | 1 year | 
| perioperative death |  | 30 days | 
| survival | Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test) | 3 years | 
| surgical complications | As defined by the Ibanez classification where it is the treatment given for a complication that gives the score. Medical and surgical complication is both mentioned and reported seperately | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, trephining, drainage, therapeutic irrigation, subdural space, postoperative complications, mortality