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Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

NCT07144423 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2026-02-09

No results posted yet for this study

Summary

Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.

Conditions

  • Chronic Subdural Hematoma

Interventions

PROCEDURE

Endoscope-assisted hematoma drainage

The procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

PROCEDURE

Burr hole hematoma drainage

The procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Guoyi Gao, MD · Beijing Tiantan Hospital

  • Liang Wu, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-19
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144423 on ClinicalTrials.gov