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DOI: 10.1055/a-1680-1870
From Research to Clinical Practice: Long-Term Impact of Randomized Clinical Trial Examining the Effect of Lumbar Drains on Cerebrospinal Fluid Leak Rates Following Endonasal Skull Base Surgery
Abstract
Intraoperative cerebrospinal fluid (CSF) leaks are associated with increased risk of postoperative CSF leaks despite multilayered reconstruction with vascularized tissue. A recent randomized controlled trial (RCT) examining the use of perioperative lumbar drains (LD) in high-risk skull base defects identified a significant reduction in postoperative CSF leak incidence (21.2 vs. 8.2%; p = 0.017). This study was conducted to assess the efficacy of the selective use of CSF diversion, for patients with intraoperative CSF leaks involving endoscopic endonasal approaches (EEA) to the skull base.
Method Consecutive endoscopic endonasal surgeries of the skull base from a pre-RCT cohort and post-RCT cohort were compared. The following case characteristics between the two cohorts were examined: patient age, body mass index (BMI), rate of revision surgery, tumor histology, use of CSF diversion, and vascularized reconstruction. The primary measured outcome was postoperative CSF leak.
Results The pre-RCT cohort included 76 patients and the post-RCT cohort included 77 patients, with dural defects in either the anterior or posterior cranial fossa (pituitary and parasellar/suprasellar surgeries excluded). There was a significant reduction in the incidence of postoperative CSF leak in the post-RCT cohort (27.6 vs. 12.9%; p = 0.04). On subgroup analysis, there was a trend toward improvement in CSF leak rate of the anterior cranial fossa (19.2 vs. 10.5%; p = 0.27), whereas CSF leak rates of the posterior cranial fossa were significantly reduced compared with the pre-RCT cohort (41.4 vs. 12.8%; p = 0.02).
Conclusion This study demonstrates that the integration of selective CSF diversion into the reconstructive algorithm improved postoperative CSF leak rates.
Publication History
Received: 20 May 2021
Accepted: 24 October 2021
Accepted Manuscript online:
27 October 2021
Article published online:
14 December 2021
© 2021. Thieme. All rights reserved.
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References
- 1 Harvey RJ, Parmar P, Sacks R, Zanation AM. Endoscopic skull base reconstruction of large dural defects: a systematic review of published evidence. Laryngoscope 2012; 122 (02) 452-459
- 2 Thorp BD, Sreenath SB, Ebert CS, Zanation AM. Endoscopic skull base reconstruction: a review and clinical case series of 152 vascularized flaps used for surgical skull base defects in the setting of intraoperative cerebrospinal fluid leak. Neurosurg Focus 2014; 37 (04) E4
- 3 Ahmed OH, Marcus S, Tauber JR, Wang B, Fang Y, Lebowitz RA. Efficacy of perioperative lumbar drainage following endonasal endoscopic cerebrospinal fluid leak repair. Otolaryngol Head Neck Surg 2017; 156 (01) 52-60
- 4 Zwagerman NT, Wang EW, Shin SS. et al. Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial. J Neurosurg 2018; 131 (04) 1172-1178
- 5 Suvarna VR. Real world evidence (RWE): are we (RWE) ready?. Perspect Clin Res 2018; 9 (02) 61-63
- 6 Webster J, Smith BD. The case for real-world evidence in the future of clinical research on chronic myeloid leukemia. Clin Ther 2019; 41 (02) 336-349