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NCT Number: NCT07688473

Surgical Management of Chronic Subdural Hematoma: Clinical Outcomes Following Single VS Double Burr Holes Evacuation

This study aims to evaluate and compare the clinical and radiological outcomes of patients with chronic subdural hematoma (CSDH) undergoing surgical evacuation using either single or double burr-hole craniostomy.

The comparison focuses on key outcome measures including recurrence rate, postoperative complications, neurological improvement, length of hospital stay, and overall functional recovery, in order to determine the most effective and safe surgical technique.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • Radiologically confirmed chronic subdural hematoma by CT and/or MRI
  • Symptomatic patients indicated for surgical evacuation
  • Patients treated by burr-hole craniostomy (single or double)

Exclusion criteria

  • Acute or subacute subdural hematomas
  • Patients managed by craniotomy flap
  • Uncorrected coagulopathy
  • Patients on anticoagulant or antiplatelet therapy without proper perioperative management
  • Patients with severe comorbid conditions significantly affecting outcomes

Treatment and study plan

Chronic Subdural Hematoma Evacuation

Procedure

Single burr-hole technique: A single burr hole was made over the maximum thickness of the hematoma followed by dural opening, irrigation with warm saline, and placement of a drain.

Double burr-hole technique: Two burr holes were created (frontal and parietal), allowing more extensive irrigation and evacuation of the hematoma, followed by drain placement.

Primary outcomes

  1. Recurrence

    Time frame: 6 months

    re-accumulation requiring re-operation

Secondary outcomes

  1. Infection

    Time frame: 6 months

    invasion and multiplication of pathogenic microorganisms in a host, causing a local or systemic immune response, which may or may not result in clinical disease.

  2. Seizures

    Time frame: 6 months

    sudden, uncontrolled electrical disturbance in the brain that can cause changes in behavior, movement, sensation, consciousness, or autonomic function

  3. Pneumocephalus

    Time frame: 6 months

    presence of air within the intracranial cavity

  4. Glasgow Coma Scale

    Time frame: 6 months

    evaluate the level of consciousness in patients with acute brain injury by assessing three components: eye opening, verbal response, and motor response.score ranges from 3 to 15, with lower scores indicating more severe impairment of consciousness.

  5. Motor Power

    Time frame: 6 months

    strength generated by voluntary contraction of a muscle or muscle group and is assessed during neurological examination to evaluate the integrity of the motor system. It is commonly graded using the Medical Research Council (MRC) Muscle Strength Scale.ranging from 0 (no contraction) to 5 (normal strength), with higher vlaues indicating better outcomes.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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