Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma

NCT06337851 | Completed

• 1 other identifier: AtaturkTRH2003/9
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Subdural Hematoma, Chronic

Keywords

Drainage; Chronic Subdural Hematoma; Consecutive; Simultaneous

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• The secondary outcome: Follow-up assessment (Age)

  One-year

• The secondary outcome: Follow-up assessment (Sex)

  One-year

• The secondary outcome: Follow-up assessment (Trauma-Relation)

  One-year

• The secondary outcome: Follow-up assessment (Concomitant Pathologies)

  One-year

• The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)

  One-year

Study Arms (2)

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.

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.

Other: Consecutive burr hole craniostomy

Interventions

Simultaneous burr hole craniostomy OTHER

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.

Simultaneous burr hole craniostomy (Group-1)

Consecutive burr hole craniostomy OTHER

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.

Consecutive burr hole craniostomy (Group-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Symptomatic bilateral hemispheric CSDH

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Izmir Ataturk Training and Research Hospital

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 10481440 BACKGROUND

• Kurokawa 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.

  PMID: 16253697 BACKGROUND

• Huang 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.

  PMID: 23707986 BACKGROUND

• Agawa 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.

  PMID: 26923835 BACKGROUND

• Sucu 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.

  PMID: 17486289 BACKGROUND

• Nakaguchi 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.

  PMID: 11059659 BACKGROUND

• Gokmen 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.

  PMID: 18666056 BACKGROUND

• Markwalder 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.

  PMID: 7264730 BACKGROUND

• Yagnik 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.

  PMID: 34647183 BACKGROUND

• Kolias 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.

  PMID: 25224156 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Omer Akar, MD

  Izmir Ataturk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor

Model Details: a prospective randomized controlled trial

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: March 29, 2024
• Study Start: November 1, 2003
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)