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

Services Institute of Medical Sciences, Pakistan

Status: Completed

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Double Burr hole Craniotomy; Procedure: Single Burr hole Craniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07368101

IRB/2024/1395/SIMS

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Double burr Hole Arm

Experimental group

Description:

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

Treatment:

Procedure: Double Burr hole Craniotomy

Single Burr Hole Arm

Experimental group

Description:

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

Treatment:

Procedure: Single Burr hole Craniotomy