NCT07688473

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 23, 2026

Last Update Submit

June 30, 2026

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    re-accumulation requiring re-operation

    6 months

Secondary Outcomes (5)

  • Infection

    6 months

  • Seizures

    6 months

  • Pneumocephalus

    6 months

  • Glasgow Coma Scale

    6 months

  • Motor Power

    6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients who underwent single burr-hole craniostomy

Procedure: Chronic Subdural Hematoma Evacuation

Group B

ACTIVE COMPARATOR

Patients who underwent double burr-hole craniostomy

Procedure: Chronic Subdural Hematoma Evacuation

Interventions

Chronic Subdural Hematoma EvacuationPROCEDURE

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.

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Related Publications (2)

  • Kumar D, Kumar A, Anwer M, Khan AV, Kumar H, Sridhar R, Hakeem A, Kumar A, Kumar A. Effectiveness of Single Versus Double Burr Hole for Chronic Subdural Hematoma: A Randomized Controlled Trial. Korean J Neurotrauma. 2026 Mar 6;22(2):149-158. doi: 10.13004/kjnt.2026.22.e11. eCollection 2026 Apr.

    PMID: 42111450BACKGROUND

  • Sale D. Single versus Double Burr Hole for Drainage of Chronic Subdural Hematoma: Randomized Controlled Study. World Neurosurg. 2021 Feb;146:e565-e567. doi: 10.1016/j.wneu.2020.10.140. Epub 2020 Oct 28.

    PMID: 33130139BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 7, 2026

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2026

Record last verified: 2026-06

Locations

EG(1)