Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage
Condition: Intracranial Hemorrhage, Hypertensive
MeSH terms: Cerebral Hemorrhage; Intracranial Hemorrhages; Intracranial Hemorrhage, Hypertensive; Hemorrhage
Study type: Interventional

Summary: 
      The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains
      controversial. Two main types of minimally invasive surgery, endoscopic evacuation and
      stereotactic aspiration, have been attempted for hematoma removal and show some advantages.
      However, prospective and controlled studies are still lacking. This is a multi-center
      randomized controlled trial designed to determine whether minimally invasive hematoma
      evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients
      with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients
      will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap
      craniotomy group in a 1:1:1 ratio.
    

Detailed description: 
      Hypertensive intracerebral hemorrhage (HICH) is the most common hemorrhagic stroke. The
      morbidity and mortality exceed 60% and only 12% patients could live independently. The choice
      of surgical or conservative treatment for patients with HICH is controversial.

      Some minimally invasive neurosurgeries have been applied to hematoma evacuation and may
      improve prognosis to some extent. In endoscopic evacuation, a small burr hole is created and
      hematoma is removed through suction and irrigation under neuroendoscope. Endoscopic surgical
      evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue.
      Stereotactic aspiration uses image guidance to place a catheter into the main body of the
      hematoma and aspirate blood. It is estimated that 720 patients (240 patients in each
      treatment group) would provide 90% power and a type I error probability of .05 to detect an
      effect size of 13% with a 10% dropout rate taken into consideration. Patients will receive
      endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of
      randomization. Patients will be followed up at 7 days, 30 days and 6 months.

      Outcomes of different groups of patients will be collected and compared. The study is
      designed to find a best surgical method for hypertensive intracerebral hemorrhage.
    

Intervention name(s): Endoscopic Evacuation; Stereotactic Aspiration; Craniotomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.; Using image guidance to aspirate hematoma.; Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Other intervention name(s): neuroendoscopic surgery; Hematoma Stereotactic Aspiration; Craniotomy evacuation of hematoma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: intracerebral hemorrhage,hypertensive; minimally invasive surgery; neuroendoscopic surgery; stereotactic aspiration