Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337851
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-01-20
Brief Title:
Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma
Sponsor:
Ataturk Training and Research Hospital
Organization:
Ataturk Training and Research Hospital
Study Overview
Official Title:
Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 favorableAlthough 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 andor patients 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 patients 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
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 andor patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None