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Irrigation of Chronic Subdural Hematomas - is More Better?

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01930617
Enrollment
1258
Registered
2013-08-29
Start date
2014-06-30
Completion date
2016-12-31
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematoma, Subdural, Chronic

Keywords

surgery, trephining, drainage, therapeutic irrigation, subdural space, postoperative complications, mortality

Brief summary

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.

Interventions

PROCEDUREBurr hole surgery with various drainage techniques

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

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
reoperations1 yearNumber of reoperations (X/N, %) between centers

Secondary

MeasureTime frameDescription
continuous irrigation versus other drainage1 yearNumber of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)
perioperative death30 days
survival3 yearsMinimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)
surgical complications30 daysAs 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

Countries

Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026