An interventional study of Simultaneous burr hole craniostomy and Consecutive burr hole craniostomy in Subdural Hematoma, Chronic, sponsored by Ataturk Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Ataturk Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
Chronic subdural hematoma (CSDH) arises at the dural border cell layer and is characterized by a pathological collection of blood, fibrin, and degradation products between the dura mater and the arachnoid mater with an insidious onset and progression. Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.Although unilateral CSDH is seen in the majority of patients, bilateral involvement is not rare in neurosurgical practices.
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.
The study is conducted as a prospective randomized controlled trial.
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 will be excluded.
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). Written consent will be taken from each patient and/or patient's relatives for the surgery and the use of data for this study.
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 The patients were operated on either under general or local anesthesia based on the recommendations of anesthesiologists and the patient's general medical status. First-generation cephalosporins were used as preoperative prophylactic antibiotics (cefazolin). 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. 12-gauge soft drainage sets with secretion bags were used for postoperative drainage in both groups.
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's enrollment of 43 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Ataturk Training and Research Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Other: Simultaneous 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.
Other: Consecutive 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.
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.
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).
Time frame: Postoperative first 12 months
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).
Time frame: Postoperative first 12 months
The secondary outcome: Follow-up assessment (Age)
The impact of age on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
Time frame: One-year
The secondary outcome: Follow-up assessment (Sex)
The impact of sex on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
Time frame: One-year
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.
Time frame: One-year
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.
Time frame: One-year
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.
Time frame: One-year
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 1. Patient alert and oriented; mild symptoms such as headache; absent or mild neurological deficit such as reflex asymmetry 2. Patient drowsy (defined as Glasgow Coma Scale (GCS) score: 13-14) or disoriented with variable neurological deficit, such as hemiparesis 3. Patient stuporous (defined as GCS 9-12) but responding appropriately to noxious stimuli; severe focal signs such as hemiplegia 4. Patient comatose (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing.
Time frame: One-year
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.
Time frame: One-year
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.
Time frame: One-year
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.
Time frame: One-year
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
Time frame: One-year
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
Time frame: One-year
Plan to share: No — Since the International Clinical Trials Registration Platform (ICTRP) became operational in 2007 and we do not have such a clinical trial registry system at the national level, the registration was made retrospectively. The first surgery date of the last patient included in the study was January 2004, and the recruitment period lasted approximately 6.5 years. This policy applies to trials that began enrolling participants on or after January 1, 2019.
Ran from Nov 2003 to primary completion in Apr 2010, 77 months.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's 77 months is above that.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Ataturk Training and Research Hospital