Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01869855
Study type Interventional
Source Kantonsspital Aarau
Contact
Status Completed
Phase N/A
Start date April 2013
Completion date January 2017

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06347796 - Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study N/A
Recruiting NCT04065113 - Middle Meningeal Artery Embolization for Chronic Subdural Hematoma N/A
Recruiting NCT02938468 - Mgt of Chronic Subdural Hematoma Using Dexamethasone Phase 2/Phase 3
Completed NCT03307395 - Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma N/A
Terminated NCT04502745 - A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation N/A
Terminated NCT03353259 - Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery Phase 2/Phase 3
Recruiting NCT02568124 - Tranexamic Acid in Chronic Subdural Hematomas Phase 2/Phase 3
Completed NCT02282228 - Detecting Chronic Subdural Hematoma With Microwave Technology N/A
Recruiting NCT05143216 - High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
Active, not recruiting NCT04816591 - Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA N/A
Recruiting NCT06401772 - The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma N/A
Completed NCT06134206 - Burr Hole Ultrasound Study N/A
Recruiting NCT03666949 - General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma N/A
Recruiting NCT03280212 - Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma Phase 3
Completed NCT03447327 - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma N/A
Recruiting NCT05374681 - Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization N/A
Recruiting NCT05267184 - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma N/A
Not yet recruiting NCT05900557 - Neurologic Deficits and Recovery in Chronic Subdural Hematoma N/A
Completed NCT02757235 - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma N/A
Terminated NCT02111785 - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma Phase 2/Phase 3