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Comparing Two Types of Brain Surgery for Sudden Bleeding Inside the Brain A Forward-Looking Study

Surgical Management of Spontaneous Intracerebral Hemorrhage-Endoscopic Versus Open Surgery- A Prospective Study - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090269
Enrollment
42
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: Neuroendoscopic Hematoma Evacuation: The intervention involved neuroendoscopic hematoma evacuation, a minimally invasive surgical technique performed under general anesthesia. A small b

Sponsors

Dr Sahil Garg
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients eligible for inclusion in the study were those diagnosed with spontaneous supratentorial intracerebral hemorrhage (ICH), confirmed through either computed tomography (CT) or magnetic resonance imaging (MRI) of the head. Inclusion criteria required a hematoma volume greater than 30 milliliters and the presence of a midline shift measuring 6 millimeters or more. Additionally, patients needed to have a Glasgow Coma Scale (GCS) score of 5 or higher to qualify. Both male and female patients between the ages of 18 and 75 years were considered for the study.

Exclusion criteria

Exclusion criteria: Patients were excluded from the study if the intracerebral hemorrhage (ICH) was secondary to underlying conditions such as tumors, aneurysms, post-infarction hemorrhage, or vascular malformations. Additional exclusion criteria included a history of trauma or head injury, the presence of coagulation disorders, or the occurrence of multiple intracranial hematomas. Major systemic comorbidities affecting life expectancy (e.g., heart, kidney, liver, lung diseases).

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study was the hematoma evacuation rate calculated using the formula preoperative hematoma volume postoperative volume / preoperative volume 100, based on CT imaging performed after surgery. This parameter was used to compare the surgical efficacy between the neuroendoscopy and open craniotomy groups.Timepoint: CT head were obtained on the post operative days 0 and 5 and at the time of discharge. Radiological data was compared with the preoperative scan

Secondary

MeasureTime frame
The secondary outcomes included postoperative Glasgow Coma Scale (GCS) at day 5 and at discharge, duration of ICU and hospital stay, incidence of rebleeding, residual hematoma, need for re-exploration surgery, postoperative complications (e.g., CSF leak, surgical site infection, meningitis, systemic infections), and mortality during hospital stay, along with functional outcome assessed at 3 months using the Extended Glasgow Outcome Scale (GOSE).Timepoint: three months

Countries

India

Contacts

Public ContactAwdhesh Kumar Yadav

King Georges Medical University

awkymail@gmail.com9919282888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026