Overview

This trial is active, not recruiting.

Condition hematoma, subdural, chronic
Treatment burr hole surgery with various drainage techniques
Sponsor St. Olavs Hospital
Collaborator Norwegian University of Science and Technology
Start date June 2014
End date December 2016
Trial size 1258 participants
Trial identifier NCT01930617, 2011/2050

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
Burr hole surgery with passive subdural drainage
burr hole surgery with various drainage techniques
Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain
Burr hole surgery with continuous irrigation
burr hole surgery with various drainage techniques
Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain
Burr hole surgery with active subgaleal drainage
burr hole surgery with various drainage techniques
Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain

Primary Outcomes

Measure
reoperations
time frame: 1 year

Secondary Outcomes

Measure
continuous irrigation versus other drainage
time frame: 1 year
perioperative death
time frame: 30 days
survival
time frame: 3 years
surgical complications
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by St. Olavs Hospital.