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Published on: March 26, 2019
Effectiveness of Single Versus Double Burr Hole for Chronic Subdural Hematoma: A Randomized Controlled Trial
Deepak Kumar1, Abhishek Kumar1, Majid Anwer1
1Department of Trauma Surgery and Critical Care, AIIMS Patna, Bihar, India.
Insights
Single burr hole craniostomy (SBHC) is non-inferior to double burr hole craniostomy (DBHC) for chronic subdural hematoma (cSDH). SBHC may be a simpler, less invasive option despite slightly higher recurrence and ventilator use.
Area of Science:
- Neurosurgery
- Surgical Outcomes
- Clinical Trials
Background:
- Chronic subdural hematoma (cSDH) management often involves burr-hole craniostomy.
- Single burr hole craniostomy (SBHC) and double burr hole craniostomy (DBHC) are common but lack comparative data.
- Understanding the comparative efficacy and safety of SBHC versus DBHC is crucial for treatment decisions.
Purpose of the Study:
- To compare clinical outcomes, complications, and recurrence rates between SBHC and DBHC in cSDH patients.
- To evaluate the non-inferiority of SBHC compared to DBHC.
- To determine the optimal surgical approach for cSDH evacuation.
Main Methods:
- Prospective, open-label, non-inferiority randomized controlled trial.
- Sixty-six cSDH patients randomized to SBHC or DBHC.
- Preoperative and 1-week/1-month postoperative assessments including GCS, CT scans, and complication monitoring.
Main Results:
- SBHC demonstrated non-inferiority to DBHC regarding non-recurrence rate (11.01% difference within 11.5% margin).
- SBHC showed a trend towards higher mortality (11.43% vs 3.12%) and significantly longer ventilator use (p=0.001).
- Recurrence and reoperation rates were higher with SBHC (20.69%) than DBHC (9.68%), though not statistically significant.
Conclusions:
- Both SBHC and DBHC are effective for cSDH evacuation.
- SBHC is non-inferior to DBHC but associated with increased recurrence and ventilator time.
- SBHC presents a potentially simpler and less invasive treatment option for cSDH.
Objective:
Burr-hole craniostomy is a common surgical intervention for patients with chronic subdural hematoma (cSDH). Single burr hole craniostomy (SBHC) and double burr hole craniostomy (DBHC) are widely practiced techniques; however, debate continues regarding the superior approach owing to limited comparative literature. This study aimed to compare the clinical outcomes, complications, and recurrence rates between SBHC and DBHC in patients with cSDH.
Methods:
This prospective, open-label, non-inferiority, randomized controlled trial was conducted at the AIIMS Patna. Sixty-six patients with cSDH were enrolled in this study and randomized to either SBHC or DBHC. Assessments were performed before surgery and at 1 week and one month after surgery. Preoperatively, no differences were observed in the non-contrast computed tomography scans, Glasgow Coma Scale scores, ventilator/intensive care unit days, recurrence, or complications. Statistical analysis was done using SPSS v22.0.
Results:
Patient characteristics were comparable between groups. One week after surgery, mortality rate was higher in the SBHC group (11.43%) than in the DBHC group (3.12%), but the difference was not statistically significant (p=0.34). The duration of ventilator use was significantly longer in the SBHC group (p=0.001). Subsequent analysis showed that recurrence and reoperation rates were higher with SBHC (20.69% each) than those with DBHC (9.68% each), although the differences were not statistically significant (p=0.13 and 0.07, respectively). Neurological improvements and radiological outcomes showed similar trends. The difference in the non-recurrence rate (11.01%) remained within the non-inferiority margin (11.5%).
Conclusion:
Both SBHC and DBHC were effective in evacuating cSDH. SBHC was shown to be non-inferior to DBHC, but had a slight increase in the recurrence rate and ventilator time. Based on patient characteristics, SBHC may be a simple and less invasive treatment option.
Trial Registration:
International Standard Randomised Controlled Trial Number Identifier: ISRCTN53688663.