randomized trial of chronic subdural hematoma and various treatment options

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: TDC, BHC: Intervention2: TWIST DRILL CRANIOSTOMY, BURR HOLE CRANIOSTOMY: STANDARD SURGICAL PROCEDURES WELL ACCEPTED Control Intervention1: BURR HOLE CRANIOSTOMY: RANDOMIZED TRIAL COMPARING BOTH PROCEDURES CONDITION: chr SDH PRIMARY OUTCOME: Re‐aspiration needed‐ to be done before discharge if patient does not reach MGS grade 0 or 1, and CT scan shows residual hematoma or air > 10mm thick; or after discharge if there is recurrence of symptoms and CT scan shows residual hematoma or air > 10mm thick‐‐‐‐‐‐Timepoint: one month SECONDARY OUTCOME: 1. GCS, KPS and Markwalder grade at discharge; 2. Neurological grade deterioration in hospital preoperatively; 3. GOS, KPS and Markwalder grade at 1 month follow‐up; 4. Time of surgery‐ prepping up to dressing; 5. Amount of lavage fluid‐ number of 500ML saline bottles used; 6. Whether effluent is clear of reddish color at closure (mild yellowish tinge acceptable); 7. Duration of hospital stay in days; 8. Radiological assessment at admission, discharge and at follow‐up‐ regarding hematoma thickness, stage, degree of atrophy and midline shift.; 9. Cost of surgery‐ hospital charges plus consumables used till discharge; 10. Complications ?respiratory, cardiac, wound infection, subdural hematoma formation, cortical damage; ‐‐‐‐‐‐Timepoint: one month INCLUSION CRITERIA: CT scan or MRI showing significant hemispheric subdural hematoma (>10mm thick).
Epistemonikos ID: 48c35e9dd6af7a3a37a279388199e3a5026f6fb3
First added on: Aug 22, 2024