Chronic Subdural Hematoma
Conditions
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.
Interventions
PROCEDURESingle Burr hole Craniotomy
Single Burr hole made at the point of highest collection of hematoma in subdural space in brain.
PROCEDUREDouble Burr hole Craniotomy
Two burr hole made in skull each at parietal eminence and around superior temporal line to drain chronic subdural hematoma
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Of Chronic Subdural Hematoma | 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 | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMuhammad Hassan Tabish, MBBS
Services Hospital / Services Institute of Medical Sciences
Outcome results
None listed