Outcome of Chronic Subdural Hematoma Management With Double Burr Hole Craniotomy Versus Single Burr Hole Craniotomy and Subdural Drain Evacuation

Outcome of Chronic Subdural Hematoma: Double Burr Hole Versus Single Burr Hole With Subdural Drain Evacuation

The goal of this clinical trial is to compare the outcome of double burr hole versus single burr hole in patients of chronic subdural hematoma undergoing subdural drain evacuation.

The main questions it aims to answers are

1. Which one of the surgical method i.e single burr hole or double burr hole is clinically superior with better post operative prognosis for the drainage of chronic subdural hematoma.

2 Compare the post operative complications in both the techniques in term of wound infection hospital stay duration , recurrence and mortality.

participants will be divided in two groups one group will be treated with single burr hole technique second group will be treated with double burr hole technique.

After procedure, patients will be followed-up in hospital until discharge and total hospital stay will be noted. Patients will be followed-up further in OPD . During follow-up, patients will be evaluated for wound infection, recurrence and mortality.

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Double Burr hole Craniotomy; Procedure: Single Burr hole Craniotomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54770
      • Services Institute of Medical Sciences / Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 20-70 years both genders diagnosed with subdural hematoma

Exclusion Criteria:

• • Patients in shock (BP≤100/60 mmHg) or history of seizures

  • Patients with bleeding disorder (PT>15 sec) or intake of anti-coagulants
  • Patients undergoing or already had ventriculoperitoneal shunt
  • Patients with epilepsy, or obsessive compulsive decoder
  • Patients with already operated for subdural hematoma
  • Patients with post-cerebrospinal fluid diversion subdural hematoma

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double burr Hole Arm; this arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma	Procedure: Double Burr hole Craniotomy; Two burr hole made in skull each at parietal eminence and around superior temporal line to drain chronic subdural hematoma
Experimental: Single Burr Hole Arm; this arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma	Procedure: Single Burr hole Craniotomy; Single Burr hole made at the point of highest collection of hematoma in subdural space in brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Of Chronic Subdural Hematoma	recurrence rate of chronic subdural hematoma evaluated if volume of sdh >15ml or significant mass effect on CT brain within 3 months post operatively	From date of surgery until radiologically confirmed recurrence (defined as subdural hematoma volume >15 mL or significant mass effect on CT brain) requiring repeat intervention, assessed up to 3 months postoperatively
quantity of hematoma evacuated	Intraoperatively evacuated hematoma quantity measured in millilitres and also includes the quantity obtained in subdural drain till 72 hours postoperatively	Measured intraoperatively at the time of surgery and cumulatively measured postoperatively from surgery until removal of the subdural drain, assessed up to 72 hours postoperatively.

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan
• Investigators: Principal Investigator: Muhammad Hassan Tabish, MBBS, Services Hospital / Services Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Actual): March 7, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: IRB/2024/1395/SIMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No