Clinical trial NCT06484374: A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma
Official title: A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematoma Brain
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Affiliated Hospital of Nantong University
name: The First People's Hospital of Lianyungang
First posted: 2024-07-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Good prognosis rate after 6 months of follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: