Irrigation of Chronic Subdural Hematomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Hematoma, Subdural, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Trondheim

Burr hole surgery with passive subdural drainage

Burr hole surgery with various drainage techniques

Intervention Type PROCEDURE

Surgical technique

1. Continuous irrigation and drainage
2. Passive subdural drain
3. Active subgaleal drain

Tromsø

Burr hole surgery with continuous irrigation

Burr hole surgery with various drainage techniques

Intervention Type PROCEDURE

Surgical technique

1. Continuous irrigation and drainage
2. Passive subdural drain
3. Active subgaleal drain

Stockholm

Burr hole surgery with active subgaleal drainage

Burr hole surgery with various drainage techniques

Intervention Type PROCEDURE

Surgical technique

1. Continuous irrigation and drainage
2. Passive subdural drain
3. Active subgaleal drain

Interventions

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Burr hole surgery with various drainage techniques

Surgical technique

1. Continuous irrigation and drainage
2. Passive subdural drain
3. Active subgaleal drain

Intervention Type PROCEDURE

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No