Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma

March 23, 2024 updated by: Hasan Kamil Sucu, Ataturk Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35360
        • Izmir Ataturk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Symptomatic bilateral hemispheric CSDH

Exclusion Criteria:

  • Hematoma thickness smaller than 10 mm on either side
  • Previously underwent any cranial surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simultaneous burr hole craniostomy (Group-1)
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
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.
Active Comparator: Consecutive burr hole craniostomy (Group-2)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Postoperative first 12 months
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).
Postoperative first 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome: Follow-up assessment (Age)
Time Frame: One-year
The impact of age on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
One-year
The secondary outcome: Follow-up assessment (Sex)
Time Frame: One-year
The impact of sex on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
One-year
The secondary outcome: Follow-up assessment (Trauma-Relation)
Time Frame: One-year
The impact of trauma-relation on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
One-year
The secondary outcome: Follow-up assessment (Concomitant Pathologies)
Time Frame: One-year
The impact of concomitant pathologies on the one-year prognosis of bilateral chronic subdural hematoma was assessed.
One-year
The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)
Time Frame: One-year
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
The secondary outcome: Follow-up assessment (The Markwalder Grading Scale)
Time Frame: One-year

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.
One-year
The secondary outcome: Follow-up assessment (Neurological Examination - Motor)
Time Frame: One-year
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
The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi)
Time Frame: One-year
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
The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign)
Time Frame: One-year
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
The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift)
Time Frame: One-year
It was evaluated whether radiological assessment findings (midline shift) affected the prognosis of bilateral CSDH. -- length measurement in mm
One-year
The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum)
Time Frame: One-year
It was evaluated whether radiological assessment findings (hematoma volume) affected the prognosis of bilateral CSDH. -- volume measurement in cm3
One-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: Omer Akar, MD, Izmir Ataturk Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2003

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

March 23, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtaturkTRH2003/9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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