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Irrigation of Chronic Subdural Hematomas - is More Better?

S

St. Olavs Hospital

Status

Completed

Conditions

Hematoma, Subdural, Chronic

Treatments

Procedure: Burr hole surgery with various drainage techniques

Study type

Observational

Funder types

Other

Identifiers

NCT01930617
2011/2050

Details and patient eligibility

About

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.

Enrollment

1,258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

1,258 participants in 3 patient groups

Trondheim
Description:
Burr hole surgery with passive subdural drainage
Treatment:
Procedure: Burr hole surgery with various drainage techniques
Tromsø
Description:
Burr hole surgery with continuous irrigation
Treatment:
Procedure: Burr hole surgery with various drainage techniques
Stockholm
Description:
Burr hole surgery with active subgaleal drainage
Treatment:
Procedure: Burr hole surgery with various drainage techniques

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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