Clinical Trial: Irrigation of Chronic Subdural Hematomas - is More Better?

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: St. Olavs Hospital

Current Primary Outcome: reoperations [ Time Frame: 1 year ]

Number of reoperations (X/N, %) between centers


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • continuous irrigation versus other drainage [ Time Frame: 1 year ]
    Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)
  • perioperative death [ Time Frame: 30 days ]
  • survival [ Time Frame: 3 years ]
    Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)
  • surgical complications [ Time Frame: 30 days ]
    As 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


Original Secondary Outcome:

  • continuous irrigation versus other drainage [ Time Frame: 1 year ]
    Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)
  • perioperative death [ Time Frame: 30 days ]
  • survival [ Time Frame: 3 years ]
    Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)
  • surgical complications [ Time Frame: 30 days ]


Information By: St. Olavs Hospital

Dates:
Date Received: August 22, 2013
Date Started: June 2014
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017