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CompletedNCT01869855Updated Jun 27, 2017

A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage

An interventional study of Subdural Drainage and Subperiosteal Drainage in Chronic Subdural Hematoma, sponsored by Kantonsspital Aarau. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-27.

Sponsored by Kantonsspital Aarau · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Subdural Hematoma

Keywords

  • chronic subdural hematoma
  • traumatic brain injury
  • burr hole trepanation
  • drainage after evacuation of chronic subdural hematoma
  • intracranial bleed
03

In context

Hematoma, Subdural

99 studies on the registry are indexed under Hematoma, Subdural; 29 are open to participants now.

This study's enrollment of 220 is above the median of 100 across 73 interventional studies indexed under Hematoma, Subdural.

Browse Hematoma, Subdural studies →

Lead sponsor

Kantonsspital Aarau is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Active comparator
    110 patients with cSDH assigned to subdural drainage

    Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.

    Procedure: Subdural Drainage

  • Active comparator
    110 patients with cSDH assigned to subperiosteal drainage

    Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.

    Procedure: Subperiosteal Drainage

Interventions

  • ProcedureSubdural Drainage
  • ProcedureSubperiosteal Drainage
06

What researchers measure

Primary outcomes

  1. Recurrence Rate

    Time frame: within the first 12 months postoiperatively

Secondary outcomes

  1. Complication rate (Morbidity)

    Time frame: within the first 12 months postoperatively

  2. Mortality

    Time frame: within the first 12 months postoperatively

  3. Outcome: Markwalder Score

    Time frame: within the first 12 months postoperatively

  4. Outcome: modified Ranking Score

    Time frame: within the first 12 months postoperatively

  5. Outcome: Glasgow Outcome Score

    Time frame: within the first 12 months postoperatively

07

Study locations

2 sites
  • Neurosurgery Kantonsspital Aarau
    Aarau, Aargau 5000, Switzerland
  • Neurosurgery University Hospital of Basel
    Basel, 4038, Switzerland
08

References and documents

Publications

  • 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. PubMed 27059872 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01869855
Lead sponsor
Kantonsspital Aarau
Responsible party
Dr. Jehuda Soleman (MD, Kantonsspital Aarau) — Principal investigator
First posted
Jun 5, 2013
Start date
Apr 2013
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jun 27, 2017
View the source record on ClinicalTrials.gov ↗

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