A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma

Not Applicable

Not yet recruiting

• Conditions: Hematoma Brain
• Interventions: Procedure: Robot-assisted minimally invasive treatment

• Registration Number: NCT06484374
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

The AI robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the therapeutic efficacy of robotic-assisted endoscopic debridement of precise minimally invasive surgical system for perioperative and long-term functional recovery of supratentorial hematomas, and to ultimately achieve the improvement of prognosis for this group of patients, and to alleviate the economic burdens on the society and the families

Detailed Description

In this randomized controlled study, we investigated the efficacy of robotic assistance for supratentorial large hematomas by comparing robotic-assisted minimally invasive removal of supratentorial large hematomas with conventional surgical hematoma removal. Our main comparisons were the 6-month mortality rate and good prognosis rate, and the main evaluation indexes included mRS score and GOS score.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Start: 2025-01-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patients who were diagnosed by imaging (CT, CTA, etc.), measured by the ABC/2 method, and clearly recognized as having a supratentorial hypertensive cerebral hemorrhage.

   Patients with hematoma volume >30mL and GCS score ≥5;

2. The patient's age is 18-70 years old; Patients aged 18-70 years;

3. Time from onset to surgery ≤72h;

4. Repeat CT scan at least 6 hours after the diagnostic CT scan showed that the hematoma was stable;

5. SBP <180 mmHg was recorded near the time of random assignment;

6. mRS score ≤1 in the past medical history;

7. Patient/family informed and signed informed consent.

Exclusion Criteria

1. The hematoma is not located on the curtain or the volume of the hematoma is less than 30 ml;
2. The onset of the disease is more than 3 days at the time of admission; Secondary cerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism).
3. secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism);
4. Presence of serious immune diseases (e.g., cirrhosis, malignant tumors, rheumatic immune diseases, etc.);
5. Poor compliance or inappropriate for enrollment as judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted minimally invasive treatment	Robot-assisted minimally invasive treatment	Minimally invasive hematoma removal with robotic assistance
Craniotomy	Robot-assisted minimally invasive treatment	Traditional craniotomy, by opening the skull and thus removing the hematoma

Primary Outcome Measures

Name	Time	Method
Good prognosis rate after 6 months of follow-up	6 months	Good prognosis rate after 6 months of follow-up