Outcome of Chronic Subdural Hematoma: Double Burr Hole Versus Single Burr Hole With Subdural Drain Evacuation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Services Institute of Medical Sciences, Pakistan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Recurrence Of Chronic Subdural Hematoma
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Double burr Hole Arm
this arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma
Intervention: Double Burr hole Craniotomy (Procedure)
Single Burr Hole Arm
this arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma
Intervention: Single Burr hole Craniotomy (Procedure)
Outcomes
Primary Outcomes
Recurrence Of Chronic Subdural Hematoma
Time Frame: 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
recurrence rate of chronic subdural hematoma evaluated if volume of sdh \>15ml or significant mass effect on CT brain within 3 months post operatively
quantity of hematoma evacuated
Time Frame: 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.
Intraoperatively evacuated hematoma quantity measured in millilitres and also includes the quantity obtained in subdural drain till 72 hours postoperatively
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Hassan tabish
Muhammad Hassan Tabish , MBBS, Neurosurgery Resident / Principal Investigator
Services Institute of Medical Sciences, Pakistan