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randomized trial of chronic subdural hematoma and various treatment options

A BLINDED RANDOMIZED STUDY OF TWIST DRILL VERSUS BURR HOLE CRANIOSTOMY FOR TREATMENT OF CHRONIC SUBDURAL HEMATOMAS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000359
Enrollment
110
Registered
2010-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: TDC, BHC: Intervention2: TWIST DRILL CRANIOSTOMY, BURR HOLE CRANIOSTOMY: STANDARD SURGICAL PROCEDURES WELL ACCEPTED Control Intervention1: BURR HOLE CRANIOSTOMY: RANDOMIZED TRIAL COMPA

Sponsors

Dr Sunil k Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CT scan or MRI showing significant hemispheric subdural hematoma (>10mm thick).

Exclusion criteria

Exclusion criteria: Thin SDH (<10mm) Small/ Unilobar SDH or post craniotomy SDH Infants or cases of birth related subdural collections Radiological doubt of hygroma/ empyema Bilateral significant lesions Large acute clot component (organized hyperdensity)*

Design outcomes

Primary

MeasureTime frame
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 thickTimepoint: one month

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Sunil K Singh
drsksingh2k@gmail.com0522-2257606

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026