Clinical trial NCT01930617: Irrigation of Chronic Subdural Hematomas - is More Better?
Official title: Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematoma, Subdural, Chronic
Keywords: surgery
trephining
drainage
therapeutic irrigation
subdural space
postoperative complications
mortality
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University Hospital of North Norway
name: Karolinska Institutet
First posted: 2013-08-29
Enrollment: 1258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients have been selected to the given therapy solely on the basis of geography. All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital and UNN, and 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).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: reoperations
timeFrame: 1 year
Secondary outcomes:
measure: continuous irrigation versus other drainage
timeFrame: 1 year
measure: perioperative death
timeFrame: 30 days
measure: survival
timeFrame: 3 years
measure: surgical complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Lars Jacob Stovner, MD PhD
role: STUDY_CHAIR
References:
citation: Sjavik K, Bartek J, Sagberg LM, Henriksen ML, Gulati S, Stahl FL, Kristiansson H, Solheim O, Forander P, Jakola AS. Assessment of drainage techniques for evacuation of chronic subdural hematoma: a consecutive population-based comparative cohort study. J Neurosurg. 2017 Jun 23;133(4):1113-1119. doi: 10.3171/2016.12.JNS161713.