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

Launched by HUASHAN HOSPITAL · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether the way a person positions their body after surgery can help prevent a condition called chronic subdural hematoma (CSDH) from coming back. CSDH occurs when blood collects on the brain's surface, often leading to symptoms like headaches, dizziness, or weakness. The researchers want to see if improving the flow of pressure in the brain through specific body postures can make a difference in recovery after surgery.

To be eligible for this trial, participants must be at least 60 years old and have a diagnosed chronic hematoma that is thicker than 1 cm, along with certain neurological symptoms before their surgery. Participants will receive a treatment called burr hole drainage to help with their condition, and they should be willing to sign an informed consent form to take part. If you or a loved one qualify, you can expect to be involved in monitoring and follow-up visits after the procedure to see how well the body posture approach works. It's important to note that certain health conditions and circumstances may exclude potential participants from joining the study, so it’s best to discuss with a healthcare provider if you think this trial could be a good option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. chronic hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
• • 2. more than 60 years of age or 60 years;
• • 3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
• • 4. 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.
• • 5. receive burr hole drainage;
• • 6. sign informed consent voluntarily.
• Exclusion Criteria:
• • 1. pregnancy or lactation;
• • 2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy
• • 3. have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up;
• • 4. patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity);
• • 5. CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery;
• • 6. have CSDH for more than 1 year or organized hematoma;
• • 7. CSDH caused by over V-P shunting;
• • 8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
• • 9. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly;
• • 10. have venous thrombosis of lower extremity or pulmonary embolism;
• • 11. cannot regular reexamine within 1 year for any reason;
• • 12. life expectancy less than 1 year;
• • 13. participating other ongoing clinical trial;
• • 14. patients are not qualified for other reason evaluated by two neurosurgeons;
• • 15. have bile reflux gastritis and esophageal diseases.