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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
| The First People's Hospital of Lianyungang | OTHER |
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This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.
This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-Assisted Endoscopic Minimally Invasive Surgery | Experimental | Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded |
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| Traditional Surgical Approaches | Sham Comparator | A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Assisted Endoscopic Minimally Invasive Surgery | Procedure | Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) score at 6 months | The primary analysis will compare differences between the two groups based on utility-weighted mRS. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal shift in mRS scores at 6 months (ordinal shift) | The difference in the distribution of scores on the modified Rankin Scale (mRS, range 0-6) between the treatment and control groups was assessed at 6 months after onset (or treatment) using a shift analysis. | up to 6 months |
| Favorable functional outcome at 6 months (mRS 0-1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Hua Hang, PhD | Contact | 025-83106666 | hang_neurosurgery@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | China |
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| Huashan Hospital |
| OTHER |
| China-Japan Friendship Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Shaoxing Central Hospital | OTHER |
| Jinhua Central Hospital | OTHER |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Shanghai East Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Aerospace Center Hospital | OTHER |
| Hebei General Hospital | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Jinshan Hospital Fudan University | OTHER |
| Minhang District Central Hospital of Shanghai | UNKNOWN |
The intervention group will undergo robot-assisted endoscopic hematoma evacuation, while the control group will receive traditional surgical approaches (such as small craniotomy or large-bone-flap intracranial hematoma evacuation).
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| Traditional Surgical Approaches | Procedure | A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap. |
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The proportion of patients achieving an excellent functional outcome (defined as mRS score of 0 or 1) at 6 months. |
| up to 6 months |
| Functional independence at 6 months (mRS 0-2) | The proportion of patients achieving functional independence (defined as mRS score of 0, 1, 2) at 6 months. | up to 6 months |
| Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire | Assessed using the EQ-5D-5L questionnaire at 6 months post-onset/post-surgery. The instrument comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity, plus a Visual Analogue Scale (EQ-VAS) | up to 6 months |
| Total length of hospital stay | Total length of hospital stay is defined as the number of days from admission to discharge from the neurosurgical unit. | up to 6 months |
| Cognitive function at 6 months | Cognitive status will be evaluated at the 6-month follow-up visit using the Montreal Cognitive Assessment (MoCA). | up to 6 months |
| Hematoma clearance rate at 48 hours postoperatively | Hematoma volumes were quantified using semi-automated planimetric analysis (e.g., 3D Slicer software) on standard non-contrast CT scans obtained at baseline and 48 hours after surgery. This method was chosen to ensure accuracy over the ellipsoid (ABC/2) method, particularly for irregular post-operative hematoma shapes | up to 6 months |
| Costs during hospitalization | Direct medical costs incurred during the inpatient period were extracted from the hospital information system. Costs were categorized into four domains: (1) surgical and anesthesia fees (including disposables); (2) ward and ICU nursing fees; (3) medication costs; and (4) diagnostic imaging and laboratory fees | up to 6 months |
| Intraoperative blood loss | Blood loss was estimated using the standard formula: $Total Loss = (Volume_{suction} - Volume_{irrigation}) + (Weight_{wet\ gauze} - Weight_{dry\ gauze}). | up to 6 months |
| Incidence of rebleeding within 14 days | Rebleeding was defined as a radiographic expansion of the hematoma volume by > 33% or an absolute increase of > 5 mL on follow-up CT scans compared with the post-operative baseline CT. | up to 6 months |
| Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs | Incidence of perioperative complications within 14 days. Specific Complications: Pulmonary Infection: Defined according to CDC criteria, requiring radiographic evidence of new infiltrates combined with clinical signs (fever, purulent sputum). Aphasia: Defined as new-onset language deficits or worsening of existing aphasia (NIHSS language subscore increase ≥ 1). Seizures: Documented clinical epileptic events confirmed by neurological examination or EEG. Deep Vein Thrombosis (DVT): Confirmed by Doppler ultrasonography screening performed between postoperative days 7 and 14. | up to 6 months |