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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06337851
Other study ID # AtaturkTRH2003/9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2003
Est. completion date April 2011

Study information

Verified date March 2024
Source Ataturk Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable. In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any. Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH Exclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery Randomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2). Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used. Radiological Evaluation Radiological evaluations will be made with CT and MR imaging. Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated. Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours. Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics. In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed. This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery.


Description:

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Study Design


Intervention

Other:
Simultaneous burr hole craniostomy
Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point.
Consecutive burr hole craniostomy
In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.

Locations

Country Name City State
Turkey Izmir Ataturk Training and Research Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary The Primary Outcome: Mortality As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful). Postoperative first 12 months
Primary The Primary Outcome: Early Postoperative Success Rate (Redo Surgery) As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful). Postoperative first 12 months
Secondary The secondary outcome: Follow-up assessment (Age) The impact of age on the one-year prognosis of bilateral chronic subdural hematoma was assessed. One-year
Secondary The secondary outcome: Follow-up assessment (Sex) The impact of sex on the one-year prognosis of bilateral chronic subdural hematoma was assessed. One-year
Secondary The secondary outcome: Follow-up assessment (Trauma-Relation) The impact of trauma-relation on the one-year prognosis of bilateral chronic subdural hematoma was assessed. One-year
Secondary The secondary outcome: Follow-up assessment (Concomitant Pathologies) The impact of concomitant pathologies on the one-year prognosis of bilateral chronic subdural hematoma was assessed. One-year
Secondary The secondary outcome: Follow-up assessment (The Glasgow Coma Scale) The assessment aimed to determine whether the Glasgow Coma Scale scores at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. The Glasgow Coma Scale is reported as the combined score (which ranges from 3 to 15) and the score of each test (E for eye from 1 to 4, V for Verbal from 1 to 5, and M for Motor from1 to 6). Higher score indicates better result. One-year
Secondary The secondary outcome: Follow-up assessment (The Markwalder Grading Scale) The assessment aimed to determine whether the Markwalder Grading Scale scores at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma.
0: Patient neurological normal
Patient alert and oriented; mild symptoms such as headache; absent or mild neurological deficit such as reflex asymmetry
Patient drowsy (defined as Glasgow Coma Scale (GCS) score: 13-14) or disoriented with variable neurological deficit, such as hemiparesis
Patient stuporous (defined as GCS 9-12) but responding appropriately to noxious stimuli; severe focal signs such as hemiplegia
Patient comatose (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing.
One-year
Secondary The secondary outcome: Follow-up assessment (Neurological Examination - Motor) The assessment aimed to determine whether the neurological examination (motor lateraling findings) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. --Motor deficit present or absent. One-year
Secondary The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi) The assessment aimed to determine whether the neurological examination (fundus oculi examination) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. -- papilledema present or absent. One-year
Secondary The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign) The assessment aimed to determine whether the neurological examination (Babinski's Sign) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. Babinski sign present or absent. One-year
Secondary The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift) It was evaluated whether radiological assessment findings (midline shift) affected the prognosis of bilateral CSDH. -- length measurement in mm One-year
Secondary The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum) It was evaluated whether radiological assessment findings (hematoma volume) affected the prognosis of bilateral CSDH. -- volume measurement in cm3 One-year
See also
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Not yet recruiting NCT06274580 - Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms N/A