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

NCT07368101 | Completed

• 1 other identifier: IRB/2024/1395/SIMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Double burr Hole Arm

EXPERIMENTAL

this arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma

Procedure: Double Burr hole Craniotomy

Single Burr Hole Arm

EXPERIMENTAL

this arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma

Procedure: Single Burr hole Craniotomy

Interventions

Single Burr hole Craniotomy PROCEDURE

Single Burr hole made at the point of highest collection of hematoma in subdural space in brain.

Single Burr Hole Arm

Double Burr hole Craniotomy PROCEDURE

Two burr hole made in skull each at parietal eminence and around superior temporal line to drain chronic subdural hematoma

Double burr Hole Arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences / Services Hospital

Lahore, Punjab Province, 54770, Pakistan

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Hassan Tabish, MBBS

  Services Hospital / Services Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Muhammad Hassan Tabish , MBBS, Neurosurgery Resident / Principal Investigator

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 26, 2026
• Study Start: October 4, 2024
• Primary Completion: March 7, 2025
• Study Completion: May 9, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)