Study of procedures for removal of chronic subdural hematoma

Not Applicable

Recruiting

Conditions: chronic subdural hematoma
chronic subdural hematoma, burr hole craniostomy
D020200

Registration Number: JPRN-jRCT1041220124

Lead Sponsor: Saito Ryuta

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1186

Inclusion Criteria

Patients with symptomatic chronic subdural hematoma requiring a surgical procedure
-20 years of age or older
-Patients undergoing surgery for a single-side CSDH
-Patients who have obtained written informed consent from the patient or an authorized representative

Exclusion Criteria

-Patients who have previously received an ipsilateral craniostomy
-Patients who have previously undergone a craniotomy
-Patients who have previously undergone cerebrospinal fluid shunting
-Patients with intracranial mass lesions that may impact current symptoms, excluding very small tumors or contralateral hematoma, etc.
-Participants who have received radiation or chemotherapy within the past five years.
-Patients with immunocompromised status
-Patients at risk of thrombosis severe enough to not tolerate discontinuation of antithrombotic medications, such as recent cardiac or intracranial stents, recent pulmonary embolism, or artificial heart valve
-Inability of the patient to cooperate or preoperatively determined that the hematoma is so small that a drain cannot be inserted
-Patients who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients who fulfill the criteria for revision surgery on the ipsilateral side within six months following initial chronic subdural hematoma surgery (Including patients who were deemed by the physician to require reoperation but were not actually operated on).

Secondary Outcome Measures

Name	Time	Method
(1) Individuals who underwent actual reoperation within six months following initial surgery<br>(2) Reoperation rate within six months postoperatively for each preoperative hematoma shape (ipsilateral)<br>(3) Alterations in mRS, GCS, and Markwalder classification after six months<br>(4) Mortality rate within six months following surgery<br>(5) Length of time from surgery to discharge (including recovery ward)<br>(6) Duration of surgical procedure transfer<br>(7) Surgical-related complications