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Determining if Cerebrospinal Fluid Prevents Recurrence of Chronic Subdural Hematoma: A Multi-Center Prospective
Hiroyuki Toi1, Yukihiko Fujii2, Toru Iwama3
11 Department of Neurosurgery, Kawasaki Medical School, Okayama, Japan.
Insights
Artificial cerebrospinal fluid (ACF) irrigation did not reduce chronic subdural hematoma (CSDH) recurrence rates compared to normal saline (NS) in CSDH surgery. Both irrigation solutions demonstrated similar safety profiles and effectiveness in preventing CSDH recurrence.
Area of Science:
- Neurosurgery
- Surgical Innovation
- Clinical Trials
Background:
- Postoperative recurrence of chronic subdural hematoma (CSDH) remains a significant clinical challenge.
- Effective irrigation solutions are crucial for minimizing recurrence after CSDH surgery.
Purpose of the Study:
- To evaluate the efficacy of artificial cerebrospinal fluid (ACF) as an irrigation solution in reducing CSDH recurrence.
- To compare the recurrence rates and safety of ACF versus normal saline (NS) in CSDH surgery.
Main Methods:
- A multi-center, prospective, randomized, open parallel group comparison study.
- Patients with CSDH were randomized to undergo burr hole drainage with either ACF or NS irrigation.
- Primary endpoint was ipsilateral CSDH recurrence within 90 days post-surgery.
Main Results:
- The overall recurrence rate was 11.4% (39/342 patients).
- Recurrence rates were similar between the ACF (11.9%) and NS (10.9%) groups (p=0.87).
- No significant difference in time to recurrence or adverse events was observed between the groups.
Conclusions:
- Artificial cerebrospinal fluid (ACF) is a safe irrigation solution for CSDH surgery.
- ACF does not significantly reduce the recurrence rate of chronic subdural hematoma compared to normal saline.
Abstract:
Over the decades, the problem of postoperative recurrence of chronic subdural hematoma (CSDH) has not been resolved. The objective of our study was to investigate whether the recurrence rate of CSDH is decreased when artificial cerebrospinal fluid (ACF) is used as irrigation solution for CSDH surgery. The present study was a multi-center, prospective, randomized, open parallel group comparison test of patients enrolled from 10 hospitals in Japan. Eligible patients with CSDH were randomly assigned to undergo burr hole drainage with either normal saline (NS) or ACF irrigation. The primary end-point was postoperative recurrence of ipsilateral CSDH. A total of 402 patients with newly diagnosed CSDH were enrolled during the study period. After applying inclusion and exclusion criteria, and taking into consideration cases lost to follow-up, our final study cohorts consisted of 177 ACF patients and 165 NS patients, representing 85.7% of the initial cohort. The overall recurrence rate was 11.4%, occurring in 39 of the 342 analyzed patients during 90 days of follow-up. Recurrence rates in the ACF and NS groups were 11.9% (21 of 177) and 10.9% (18 of 165), respectively. No significant difference was evident between groups (p = 0.87). In addition, no significant difference in time to recurrence was seen between groups (p = 0.74). No serious adverse effects related to irrigation fluid were seen in either group. Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups. However, ACF offers sufficient safety as irrigation fluid for CSDH.
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