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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Kantonsspital Aarau
Sponsor:
Information provided by (Responsible Party):
Dr. Jehuda Soleman, Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT01869855
First received: June 2, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Subdural Hematoma
Procedure: Subdural Drainage
Procedure: Subperiosteal Drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Subperiosteal Drainage Versus Subdural Drainage in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: a Randomized Controlled Trial

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Recurrence Rate [ Time Frame: within the first 12 months postoiperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication rate (Morbidity) [ Time Frame: within the first 12 months postoperatively ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: within the first 12 months postoperatively ] [ Designated as safety issue: Yes ]
  • Outcome: Markwalder Score [ Time Frame: within the first 12 months postoperatively ] [ Designated as safety issue: No ]
  • Outcome: modified Ranking Score [ Time Frame: within the first 12 months postoperatively ] [ Designated as safety issue: No ]
  • Outcome: Glasgow Outcome Score [ Time Frame: within the first 12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 150 patients with cSDH assigned to subdural drainage
Randomization of 150 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 300 patients included in the study.
Procedure: Subdural Drainage
Active Comparator: 150 patients with cSDH assigned to subperiosteal drainage
Randomization of 150 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 300 patients included in the study.
Procedure: Subperiosteal Drainage

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • A subdural drainage cannot be placed due to intraoperative circumstances (e.g. brain unfolds)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869855

Contacts
Contact: Jehuda Soleman, MD +41628384141 neurosurgery@ksa.ch
Contact: Javier Fandino, Prof, MD +41628384141 neurosurgery@ksa.ch

Locations
Switzerland
Neurosurgery Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5000
Contact: Jehuda Soleman, MD    +41628384141    neurosurgery@ksa.ch   
Contact: Javier Fandino, Prof., MD    +41628384141    neurosurgery@ksa.ch   
Principal Investigator: Jehuda Soleman, MD         
Sub-Investigator: Javier Fandino, Prof., MD         
Sub-Investigator: Frederic Rossi, MD         
Sponsors and Collaborators
Kantonsspital Aarau
  More Information

No publications provided

Responsible Party: Dr. Jehuda Soleman, MD, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT01869855     History of Changes
Other Study ID Numbers: CSDH-KSA
Study First Received: June 2, 2013
Last Updated: June 2, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Aarau:
chronic subdural hematoma
traumatic brain injury
burr hole trepanation
drainage after evacuation of chronic subdural hematoma
intracranial bleed

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014