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The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are:
Participants in the experimental group will:
If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted minimally invasive puncture and aspiration surgery | Experimental | The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage |
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| Standard medical management | Active Comparator | The control group will undergo conventional medical conservative management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted minimally invasive puncture and aspiration surgery | Procedure | Positioning and surgical operation will be performed according to the robot navigation system protocols. Preoperative imaging data will be used for precise surgical planning, including the construction of a three-dimensional (3D) preoperative visualization model. The 3D reconstruction and CT data will be imported into the AI robot-assisted stereotactic system, which, after mapping to the patient's skull, automatically designs the surgical target, calculates coordinate values, plans the puncture trajectory, and determines the cranial entry point. Different surgical approaches will be selected based on the location and shape of the hematoma, and individualized parameters, including puncture direction and trajectory length, will be generated for each patient. During the procedure, the robot will assist with stereotactic puncture, while the patient's heart rate and blood pressure are closely monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | 60 days survival rate after follow-up | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal shift in mRS scores at 60 days and 6 months | The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. | 60 days and 6 months |
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Participants must meet all of the following inclusion criteria:
Patients will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbing Yu, M.D. | Contact | +86-13901114963 | yuyanbing123@126.com | |
| Yulian Zhang, M.D. | Contact | +86-13051581507 | 398824625@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanbing Yu, M.D. | China-Japan Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3992454 | Background | Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3. |
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The study has not yet begun; we will decide once recruitment starts.
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| Standard medical management | Other | According to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed. |
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| Favorable functional outcome at 60 days and 6 months (mRS 0-1) |
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. |
| 60 days and 6 months |
| Functional independence at 60 days and 6 months (mRS 0-2) | The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. | 60 days and 6 months |
| Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire | Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire | 60 days and 6 months |
| Utility-weighted mRS at 60 days and 6 months | The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. | 60 days and 6 months |
| Cognitive function at 60 days and 6 months | Cognitive function at 60 days and 6 months | 60 days and 6 months |
| Total length of hospital stay | Total length of hospital stay | 60 days |
| Costs during hospitalization | Costs during hospitalization | 60 days |
| ICU length of stay | ICU length of stay | 60 days |
| Brainstem hematoma clearance rate on postoperative days 1, 3, and 7 | The change in hematoma volume compared to the preoperative CT scan was assessed 1, 3, and 7 days postoperatively. | 1, 3, and 7 days |
| Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis | Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis | 14 days |
| Aerospace Center Hospital | Beijing | Beijing Municipality | 100049 | China |
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| Hebei Provincial People's Hospital | Shijiazhuang | Hebei | 100190 | China |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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