Clinical Trial: To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlle

Brief Summary:

Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.

The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.

The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.


Detailed Summary:

Background

Chronic subdural hematoma (CSH) is one of the most common intracranial bleedings in patients over 60 years of age and a frequently found neurosurgical entity. Age related brain atrophy leads to enlargement of the subarachnoid space, a space limited by the dura mater and the arachnoid membrane. Blood vessels that occupy this space are being stretched and may rupture after a minor head trauma. Although the resulting bleeding itself is often without noticeable consequence for the patient, the anatomical outcome may be serious as it enlarges the subdural space. The formation of new leaky capillary-like vessels and/or volume enhancing osmotic gradients lead to the enlargement of the subdural hematoma over weeks, filling the intracranial space and compressing the brain. Headaches, gait disturbances, language problems, hemiparesis and decreased consciousness are among the many presenting symptoms and tend to develop over days or weeks.

Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head typically reveals the blood accumulation in the subdural space. Standard treatment includes the evacuation of the subdural blood through burr holes (see below) under either local or general anesthesia. In cases when a hematoma clot cannot be evacuated through burr holes a small craniotomy is performed. CSH is feared for its high recurrence rate (between 9 and 27%) that mostly occurs within 3 months of the initial operation.

The optimal follow-up course for operated patients remains controversial. Due to the high rate of recurrences, one strategy is to perform serial CT scans in order to identify recurrent hematomas early. The radiologic evidence of a recurrent or significant persistent hematoma often leads to reoperation. Another strategy after surgical hematoma
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: modified Rankin Scale [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of reoperation [ Time Frame: 6 months ]
  • Mini Mental Status [ Time Frame: 6 months ]
  • NIHSS [ Time Frame: 6 months ]
  • QLQ-C30 [ Time Frame: 6 months ]
  • Total length of hospitalisation [ Time Frame: 6 months ]
  • Influence of the size and radiological features of the hematoma on rate of recurrence [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Rate of reoperation [ Time Frame: 6 months ]
  • Functional status: Mini Mental Status, NIHSS, QLQ-C30 [ Time Frame: 6 months ]
  • Total length of hospitalisation [ Time Frame: 6 months ]
  • Influence of the size and radiological features of the hematoma on rate of recurrence [ Time Frame: 6 months ]


Information By: University Hospital Inselspital, Berne

Dates:
Date Received: June 18, 2012
Date Started: June 1, 2012
Date Completion:
Last Updated: February 10, 2017
Last Verified: February 2017