FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR).
FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR). In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The study will be conducted in all five neurosurgical departments in Finland. To determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. Secondary outcomes in our study include mortality, neurological outcome and complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
587
Operation with irrigation
Operation without irrigation
Helsinki University Hospital
Helsinki, Finland
Rate of re-operations of ipsilateral chronic subdural hematoma
Rate of reoperations between groups
Time frame: From operation up to 6 months after postoperatively
Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation
Modified Rankin scale ranges from 1 to 6, where 1 indicates normal daily functionality and 6 indicates death
Time frame: At baseline, and at 2 and 6 months after operation
Rate of mortality between intervention groups
Rate of mortality between intervention groups
Time frame: From operation up to 6 months postoperatively
Duration of the operation between groups
Time (minutes) used to complete the operation, from incision to last suture
Time frame: Intraoperative measure
Hospital length of stay between groups
The duration of the stay in hospital (days)
Time frame: From operation up to six months
Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively
The volume of CSDH will be measured from preoperative CT or MRI and at 2 months after operation CT or MRI
Time frame: Immediate preoperative and 2 months postoperatively
Rate of complications and adverse events within 6 months
Rate of complication rate between groups
Time frame: within 6 months after operation
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