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Trials / Recruiting

RecruitingNCT06894433

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
280 (estimated)
Sponsor
Southwest Hospital, China · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Detailed description

Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.

Conditions

Interventions

TypeNameDescription
PROCEDUREneuroendoscopic surgerySubjects will receive Neuroendoscopic Surgery followed by standard medical management
PROCEDUREcraniotomySubjects will receive Craniotomy followed by standard medical management

Timeline

Start date
2025-06-01
Primary completion
2028-06-30
Completion
2028-12-31
First posted
2025-03-25
Last updated
2025-05-18

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06894433. Inclusion in this directory is not an endorsement.