Subdural Hematoma, ChronicNCT06337851
Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma
A study testing Simultaneous burr hole craniostomy and Consecutive burr hole craniostomy in people with Subdural Hematoma, Chronic, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma, Chronic
- What is being tested?
- Simultaneous burr hole craniostomy and Consecutive burr hole craniostomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2003to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic bilateral hemispheric CSDH
Who cannot join
- Hematoma thickness smaller than 10 mm on either side
- Previously underwent any cranial surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Ataturk Training and Research Hospital
Izmir, 35360
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Subdural Hematoma, Chronic
- Being tested
- Simultaneous burr hole craniostomy, Consecutive burr hole craniostomy
- Keywords
- Drainage, Chronic Subdural Hematoma, Consecutive, Simultaneous
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous burr hole craniostomyOther
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 craniostomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous burr hole craniostomy (Group-1) | Active comparator | 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. Receives: Other: Simultaneous burr hole craniostomy |
| Consecutive burr hole craniostomy (Group-2) | Active comparator | 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. Receives: Other: Consecutive burr hole craniostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Postoperative first 12 months
Secondary outcomes (11)
The secondary outcome: Follow-up assessment (Age)
The impact of age on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study startNov 2003
- Primary completionApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Subdural Hematoma, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kamil Sucu, Ataturk Training and Research Hospital
- Investigators
- Omer Akar, MD, Principal investigator, Izmir Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337851
- Sponsor's protocol ID
- AtaturkTRH2003/9
- Status last verified
- Mar 2024
- First submitted
- 20 Jan 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Okuchi K, Fujioka M, Maeda Y, Kagoshima T, Sakaki T. Bilateral chronic subdural hematomas resulting in unilateral oculomotor nerve paresis and brain stem symptoms after operation--case report. Neurol Med Chir (Tokyo). 1999 May;39(5):367-71. doi: 10.2176/nmc.39.367.
PubMed 10481440Kurokawa Y, Ishizaki E, Inaba K. Bilateral chronic subdural hematoma cases showing rapid and progressive aggravation. Surg Neurol. 2005 Nov;64(5):444-9; discussion 449. doi: 10.1016/j.surneu.2004.12.030.
PubMed 16253697Huang YH, Yang KY, Lee TC, Liao CC. Bilateral chronic subdural hematoma: what is the clinical significance? Int J Surg. 2013;11(7):544-8. doi: 10.1016/j.ijsu.2013.05.007. Epub 2013 May 24.
PubMed 23707986Agawa Y, Mineharu Y, Tani S, Adachi H, Imamura H, Sakai N. Bilateral Chronic Subdural Hematoma is Associated with Rapid Progression and Poor Clinical Outcome. Neurol Med Chir (Tokyo). 2016;56(4):198-203. doi: 10.2176/nmc.oa.2015-0256. Epub 2016 Feb 29.
PubMed 26923835Sucu HK, Gokmen M, Ergin A, Bezircioglu H, Gokmen A. Is there a way to avoid surgical complications of twist drill craniostomy for evacuation of a chronic subdural hematoma? Acta Neurochir (Wien). 2007 Jun;149(6):597-9. doi: 10.1007/s00701-007-1162-9. Epub 2007 May 7.
PubMed 17486289Nakaguchi H, Tanishima T, Yoshimasu N. Relationship between drainage catheter location and postoperative recurrence of chronic subdural hematoma after burr-hole irrigation and closed-system drainage. J Neurosurg. 2000 Nov;93(5):791-5. doi: 10.3171/jns.2000.93.5.0791.
PubMed 11059659Gokmen M, Sucu HK, Ergin A, Gokmen A, Bezircio Lu H. Randomized comparative study of burr-hole craniostomy versus twist drill craniostomy; surgical management of unilateral hemispheric chronic subdural hematomas. Zentralbl Neurochir. 2008 Aug;69(3):129-33. doi: 10.1055/s-2007-1004587. Epub 2008 Jul 29.
PubMed 18666056Markwalder TM, Steinsiepe KF, Rohner M, Reichenbach W, Markwalder H. The course of chronic subdural hematomas after burr-hole craniostomy and closed-system drainage. J Neurosurg. 1981 Sep;55(3):390-6. doi: 10.3171/jns.1981.55.3.0390.
PubMed 7264730Yagnik KJ, Goyal A, Van Gompel JJ. Twist drill craniostomy vs burr hole drainage of chronic subdural hematoma: a systematic review and meta-analysis. Acta Neurochir (Wien). 2021 Dec;163(12):3229-3241. doi: 10.1007/s00701-021-05019-3. Epub 2021 Oct 14.
PubMed 34647183Kolias AG, Chari A, Santarius T, Hutchinson PJ. Chronic subdural haematoma: modern management and emerging therapies. Nat Rev Neurol. 2014 Oct;10(10):570-8. doi: 10.1038/nrneurol.2014.163. Epub 2014 Sep 16.
PubMed 25224156
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT06337851
- Acronym / sponsor ID
- AtaturkTRH2003/9
- Conditions
- Subdural Hematoma, Chronic
- Keywords
- Drainage, Chronic Subdural Hematoma, Consecutive, Simultaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Nov 2003 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Simultaneous burr hole craniostomy (Group-1) | Active comparator | Other: Simultaneous burr hole craniostomyPatients 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 (Group-2) | Active comparator | Other: Consecutive burr hole craniostomyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic bilateral hemispheric CSDH
Key exclusion criteria (2 listed)
- Hematoma thickness smaller than 10 mm on either side
- Previously underwent any cranial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous burr hole craniostomyPatients 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 (Group-1) |
| Consecutive burr hole craniostomyIn 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. | Other | Consecutive burr hole craniostomy (Group-2) |
Primary outcome
The Primary Outcome: Mortality
Time frame: Postoperative first 12 months
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).
The Primary Outcome: Early Postoperative Success Rate (Redo Surgery)
Time frame: Postoperative first 12 months
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).
11 secondary outcomes
The secondary outcome: Follow-up assessment (Age)
Time frame: One-year
The secondary outcome: Follow-up assessment (Sex)
Time frame: One-year
The secondary outcome: Follow-up assessment (Trauma-Relation)
Time frame: One-year
The secondary outcome: Follow-up assessment (Concomitant Pathologies)
Time frame: One-year
The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)
Time frame: One-year
The secondary outcome: Follow-up assessment (The Markwalder Grading Scale)
Time frame: One-year
The secondary outcome: Follow-up assessment (Neurological Examination - Motor)
Time frame: One-year
The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi)
Time frame: One-year
The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign)
Time frame: One-year
The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift)
Time frame: One-year
The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum)
Time frame: One-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 10481440Okuchi K, Fujioka M, Maeda Y, Kagoshima T, Sakaki T. Bilateral chronic subdural hematomas resulting in unilateral oculomotor nerve paresis and brain stem symptoms after operation--case report. Neurol Med Chir (Tokyo). 1999 May;39(5):367-71. doi: 10.2176/nmc.39.367.
- Background: PubMed 16253697Kurokawa Y, Ishizaki E, Inaba K. Bilateral chronic subdural hematoma cases showing rapid and progressive aggravation. Surg Neurol. 2005 Nov;64(5):444-9; discussion 449. doi: 10.1016/j.surneu.2004.12.030.
- Background: PubMed 23707986Huang YH, Yang KY, Lee TC, Liao CC. Bilateral chronic subdural hematoma: what is the clinical significance? Int J Surg. 2013;11(7):544-8. doi: 10.1016/j.ijsu.2013.05.007. Epub 2013 May 24.
- Background: PubMed 26923835Agawa Y, Mineharu Y, Tani S, Adachi H, Imamura H, Sakai N. Bilateral Chronic Subdural Hematoma is Associated with Rapid Progression and Poor Clinical Outcome. Neurol Med Chir (Tokyo). 2016;56(4):198-203. doi: 10.2176/nmc.oa.2015-0256. Epub 2016 Feb 29.
- Background: PubMed 17486289Sucu HK, Gokmen M, Ergin A, Bezircioglu H, Gokmen A. Is there a way to avoid surgical complications of twist drill craniostomy for evacuation of a chronic subdural hematoma? Acta Neurochir (Wien). 2007 Jun;149(6):597-9. doi: 10.1007/s00701-007-1162-9. Epub 2007 May 7.
- Background: PubMed 11059659Nakaguchi H, Tanishima T, Yoshimasu N. Relationship between drainage catheter location and postoperative recurrence of chronic subdural hematoma after burr-hole irrigation and closed-system drainage. J Neurosurg. 2000 Nov;93(5):791-5. doi: 10.3171/jns.2000.93.5.0791.
- Background: PubMed 18666056Gokmen M, Sucu HK, Ergin A, Gokmen A, Bezircio Lu H. Randomized comparative study of burr-hole craniostomy versus twist drill craniostomy; surgical management of unilateral hemispheric chronic subdural hematomas. Zentralbl Neurochir. 2008 Aug;69(3):129-33. doi: 10.1055/s-2007-1004587. Epub 2008 Jul 29.
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- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Akar, MD principal investigator
Izmir Ataturk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous burr hole craniostomy and Consecutive burr hole craniostomy in people with Subdural Hematoma, Chronic, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome: Mortality (time frame: Postoperative first 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337851, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.