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

June 30, 2026 updated by: Hatem Yousry, Sohag University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Patients who underwent single burr-hole craniostomy
Procedure: Chronic Subdural Hematoma Evacuation

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.
Active Comparator: Group B
Patients who underwent double burr-hole craniostomy
Procedure: Chronic Subdural Hematoma Evacuation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 6 months
re-accumulation requiring re-operation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Seizures
Time Frame: 6 months
sudden, uncontrolled electrical disturbance in the brain that can cause changes in behavior, movement, sensation, consciousness, or autonomic function
6 months
Pneumocephalus
Time Frame: 6 months
presence of air within the intracranial cavity
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-6-14MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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