The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

The BP-CSDH study is a prospective, multicentre, open-label, randomised controlled trial with blinded endpoint assessment. 830 eligible patients will be randomised 1:1 to body posture therapy group or the control group. Follow-up assessments will be conducted at 30 days (±7 days), 90 days (±10 days) and 365 days(±30 days) post-surgery.

Inclusion criteria

• chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
• more than 60 years of age or 60 years;
• MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
• patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
• receive burr hole drainage;
• sign informed consent voluntarily.

Exclusion criteria

• have brain hernia or acute massive cerebral infarction that have to perform craniotomy
• have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
• Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
• Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
• Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;
• CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
• CSDH caused by over V-P shunting;
• during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
• Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
• have deep venous thrombosis of lower extremity or pulmonary embolism;
• cannot complete regular reexamine within 1 year for any reason;
• life expectancy less than 1 year;
• participating other ongoing clinical trial;
• patients are not qualified for other reason evaluated by two neurosurgeons;
• have bile reflux gastritis and esophageal diseases.