Irrigation of Chronic Subdural Hematomas - is More Better?

Completed

• Conditions: Hematoma, Subdural, Chronic
• Interventions: Procedure: Burr hole surgery with various drainage techniques

• Registration Number: NCT01930617
• Lead Sponsor: St. Olavs Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-29
• Study Start: 2014-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-24
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1258

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trondheim	Burr hole surgery with various drainage techniques	Burr hole surgery with passive subdural drainage
Tromsø	Burr hole surgery with various drainage techniques	Burr hole surgery with continuous irrigation
Stockholm	Burr hole surgery with various drainage techniques	Burr hole surgery with active subgaleal drainage

Primary Outcome Measures

Name	Time	Method
reoperations	1 year	Number of reoperations (X/N, %) between centers

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden