A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage
Primary Purpose
Chronic Subdural Hematoma
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Subdural Drainage
Subperiosteal Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, traumatic brain injury, burr hole trepanation, drainage after evacuation of chronic subdural hematoma, intracranial bleed
Eligibility Criteria
Inclusion Criteria:
- Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma
- Chronic subdural hematoma verified on cranial CT or MRI
Exclusion Criteria:
- The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy)
- Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt)
- no informed consent
Sites / Locations
- Neurosurgery Kantonsspital Aarau
- Neurosurgery University Hospital of Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
110 patients with cSDH assigned to subdural drainage
110 patients with cSDH assigned to subperiosteal drainage
Arm Description
Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.
Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.
Outcomes
Primary Outcome Measures
Recurrence Rate
Secondary Outcome Measures
Complication rate (Morbidity)
Mortality
Outcome: Markwalder Score
Outcome: modified Ranking Score
Outcome: Glasgow Outcome Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01869855
Brief Title
A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage
Official Title
Use of Subperiosteal Drainage Versus Subdural Drainage in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau
4. Oversight
5. Study Description
Brief Summary
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.
Detailed Description
Chronic subdural haematoma (cSDH) is one of the most frequent neurosurgical entities, affecting elderly people and associated with substantial morbidity and mortality. Its incidence is reported to be 1.7-13.1 per 100000 inhabitants per year, yet there has been a steady increasing incidence as the result of prolonged life expectancy in recent years. Surgical treatment is recommended in case of neurological symptoms. In the only evidence based review of the different surgical treatment modalities of cSDH, Weigels study group concluded that bure-hole craniostomy with irrigation and drainage has the best cure to complication ratio. A randomized controlled study of Santarius and his colleagues showed a reduced recurrence and mortality while placing a subdural drainage compared to no drainage after burr hole evacuation of cSDH. Gazzeri et al. and Zumofen et al. used closed subperiosteal drainage instead of the commonly used subdural drainage. They showed equal or superior results in outcome, complications and postoperative symptoms compared to previous studies. Since the subperiosteal drainage is not positioned in direct contact to cortical structures, bridging veins or haematoma membranes it is considered safer and should be favored over a subdural drainage. Bellut et al. compared in their institute retrospectively 48 patients treated with subperiosteal drainage to 65 patients with subdural drainage and found no difference in recurrence rate of cSDH, yet less mortality and fewer serious complications in the group treated with subperiosteal drainage. However in their study none of the results showed a significant difference, and they concluded that further randomized studies with larger patient number are needed. In a recently published prospective randomized study Kaliaperumal et al. concluded that the recurrence rate in subperiosteal drainage is equal to subdural drainage, yet the modified ranking scale(mRS) of the patients with subperiosteal drainage after 6 months was significantly better. However, the mRS score preoperative were better in the subperiosteal drain group causing a statistical bias. In addition the amount patients studied was small (25 per group) and the recurrence rate was overall at 0%, with a very low morbidity and mortality compared to the literature. Due to these bias the authors recommend further prospective and randomized studies with larger group of patients.
To date in neurosurgery practice evidence based guidelines on which drainage should be used in cSDH do not exist and both methods, subdural drainage and subperiosteal drainage, are being practiced, depending on the institute and/or the practicing neurosurgeon.
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, traumatic brain injury, burr hole trepanation, drainage after evacuation of chronic subdural hematoma, intracranial bleed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
110 patients with cSDH assigned to subdural drainage
Arm Type
Active Comparator
Arm Description
Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.
Arm Title
110 patients with cSDH assigned to subperiosteal drainage
Arm Type
Active Comparator
Arm Description
Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.
Intervention Type
Procedure
Intervention Name(s)
Subdural Drainage
Intervention Type
Procedure
Intervention Name(s)
Subperiosteal Drainage
Primary Outcome Measure Information:
Title
Recurrence Rate
Time Frame
within the first 12 months postoiperatively
Secondary Outcome Measure Information:
Title
Complication rate (Morbidity)
Time Frame
within the first 12 months postoperatively
Title
Mortality
Time Frame
within the first 12 months postoperatively
Title
Outcome: Markwalder Score
Time Frame
within the first 12 months postoperatively
Title
Outcome: modified Ranking Score
Time Frame
within the first 12 months postoperatively
Title
Outcome: Glasgow Outcome Score
Time Frame
within the first 12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma
Chronic subdural hematoma verified on cranial CT or MRI
Exclusion Criteria:
The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy)
Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt)
no informed consent
Facility Information:
Facility Name
Neurosurgery Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5000
Country
Switzerland
Facility Name
Neurosurgery University Hospital of Basel
City
Basel
ZIP/Postal Code
4038
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27059872
Citation
Soleman J, Lutz K, Schaedelin S, Mariani L, Fandino J. Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Apr 8;5(2):e38. doi: 10.2196/resprot.5339.
Results Reference
derived
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A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage
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