medwireNews: The use of irrigation as part of burr-hole drainage surgery for subdural hematomas may be preferable to carrying out the procedure without irrigation, say investigators in the FINISH study.
“Although the benefit of the subdural drain in burr-hole surgery for chronic subdural haematomas is established, and its use has now become commonplace, the question of whether drain usage renders subdural irrigation redundant remain[s] unresolved,” note Rahul Raj (Helsinki University Hospital, Finland) and colleagues.
To answer this question, the researchers carried out a noninferiority study in which they randomly assigned 589 patients (mean age 77.6 years; 72% men) from five neurosurgery centers in Finland to receive either burr-hole drainage with irrigation (n=294) or without irrigation (n=295).
In all, 75% of the participants had a documented history of head trauma, 47% had a history of preoperative antithrombotic medication use, and 26% of patients with available scans showed a preoperative bilateral hematoma.
The investigators write in The Lancet that 15.4% of patients overall met the primary endpoint of reoperation over the 6 months of follow-up. This outcome occurred in a third fewer patients who underwent burr-hole drainage with irrigation than without, at 12.6% versus 18.3%, giving a nonsignificant 5.7 percentage point difference in favor of irrigation.
The 95% confidence interval for the difference ranged from 0.2 to 11.7, the researchers note, which was above the prespecified noninferiority margin of 7.5% meaning the results failed to show noninferiority of burr-hold draining without irrigation.
They also found no significant difference at 6 months between the patients who did and did not receive irrigation in terms of unfavorable functional outcome, with a respective 12.6% and 13.1% having a modified Rankin Scale score of 0–4, mortality (7.1 vs 6.1%), or adverse events (29.6 vs 30.9%).
Altogether, the findings “favour the use of subdural irrigation,” say Raj et al, who estimate that 17.5 patients would need to be treated with irrigation to avoid one reoperation.
In a related comment, Keita Shibahashi (Tokyo Metropolitan Bokutoh Hospital, Japan) remarks that “[g]iven that subdural irrigation required only an additional median operating time of 4 min and yielded no increase in adverse events, this intervention is expected to alleviate physical burdens to patients and economic burdens to health-care systems through fewer reoperations.”
He adds, however, that potential considerations include the possible variation in irrigation procedures among the different centers and the lack of quantitative assessment of postoperative pneumocephalus status, which can affect drainage outcomes, as the study did not involve an immediate postoperative computed tomography scan.
Shibahashi therefore emphasizes “the importance of additional external validation for these results.”
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Lancet 2024; doi:10.1016/S0140-6736(24)00686-X
Lancet 2024; doi: 10.1016/S0140-6736(24)00879-1
