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CSF Rhinorrhea After Endonasal Intervention to the Skull Base (CRANIAL) — Part 2:Impact of COVID-19

Background During the pandemic, there has been a concern about the increased risk of perioperative mortality for patients with COVID-19, and the transmission risk to healthcare workers, particularly during endonasal neurosurgical operations. The Pituitary Society produced recommendations to guide management during this era. We sought to assess contemporary neurosurgical practice and the impact of COVID-19. Methods A multicentre, prospective, observational cohort study was conducted at twelve tertiary neurosurgical units (UK and Ireland). Data were collected from March 23rd-July 31st, 2020 inclusive. Data points collected were patient demographics, pre-operative COVID-19 testing, intra-operative operative modifications, and 30-day COVID infection rates. Results 124 patients were included. 116 patients (n=116/124, 94%) underwent COVID-19 testing pre-operatively (TSA: 97/105, 92%; EEA: 19/19, 100%). One patient (n=1/115, 1%) tested positively for COVID-19 pre-operatively, requiring a delay of operation until the infection was confirmed as resolved. Asides from transient diabetes insipidus; no other complications were reported for this case. All theatre staff wore at least level 2 PPE. Adaptations to surgical techniques included minimising drilling, draping modifications, and using nasal iodine wash. At 30 days postoperatively, there was no evidence of COVID infection (symptoms or on formal testing) in our cohort, and no mortality. Conclusions Preoperative screening protocols and operative modifications have facilitated endonasal neurosurgery during the COVID-19 pandemic, with Pituitary Society guidelines followed for the majority of these operations. There was no evidence of COVID infection in our cohort, and no mortality, supporting the use of risk mitigation strategies to continue endonasal neurosurgery in subsequent pandemic waves

CSF Rhinorrhoea After Endonasal Intervention to the Skull Base (CRANIAL) - Part 1: Multicenter Pilot Study

Background: CRANIAL (CSF Rhinorrhoea After Endonasal Intervention to the Skull Base) is a prospective, multicentre observational study seeking to determine: (1) the scope of skull base repair methods used; and (2) corresponding rates of postoperative CSF rhinorrhoea in endonasal transsphenoidal (TSA) expanded endonasal approaches (EEA) for skull base tumours. We sought to pilot the project - assessing the feasibility and acceptability by gathering preliminary data. / Methods: A prospective, observational cohort pilot study was carried out at twelve tertiary UK neurosurgical units. Feedback regarding project positives and challenges were qualitatively analysed. / Results: 187 cases were included, 159 TSA (85%) and 28 EEA (15%). The most common pathologies included: pituitary adenomas (n=141/187), craniopharyngiomas (n=13/187) and skull-base meningiomas (n=4/187). The most common skull base repair techniques used were tissue glues (n=132/187, most commonly Tisseel®), grafts (n=94/187, most commonly fat autograft or Spongostan™) and vascularised flaps (n=51/187, most commonly nasoseptal). These repairs were most frequently supported by nasal packs (n=125/187) and lumbar drains (n=22/187). Biochemically-confirmed CSF rhinorrhoea occurred in 6/159 (3.8%) TSA and 2/28 (7.1%) EEA. Four TSA (3%) and two EEA (7%) cases required operative management for CSF rhinorrhoea (CSF diversion or direct repair). Qualitative feedback was largely positive (themes included: user-friendly and efficient data collection, strong support from senior team members) demonstrating acceptability. / Conclusions: Our pilot experience highlights the acceptability and feasibility of CRANIAL. There is a precedent for multicentre dissemination of this project, in order to establish a benchmark of contemporary skull base neurosurgery practice, particularly with respect to EEA cases

CSF Rhinorrhoea After Endonasal Intervention to the Skull Base (CRANIAL) - Part 1:Multicenter Pilot Study

Background CRANIAL (CSF Rhinorrhoea After Endonasal Intervention to the Skull Base) is a prospective, multicentre observational study seeking to determine: (1) the scope of skull base repair methods used; and (2) corresponding rates of postoperative CSF rhinorrhoea in endonasal transsphenoidal (TSA) expanded endonasal approaches (EEA) for skull base tumours. We sought to pilot the project - assessing the feasibility and acceptability by gathering preliminary data. Methods A prospective, observational cohort pilot study was carried out at twelve tertiary UK neurosurgical units. Feedback regarding project positives and challenges were qualitatively analysed. Results 187 cases were included, 159 TSA (85%) and 28 EEA (15%). The most common pathologies included: pituitary adenomas (n=141/187), craniopharyngiomas (n=13/187) and skull-base meningiomas (n=4/187). The most common skull base repair techniques used were tissue glues (n=132/187, most commonly Tisseel®), grafts (n=94/187, most commonly fat autograft or Spongostan™) and vascularised flaps (n=51/187, most commonly nasoseptal). These repairs were most frequently supported by nasal packs (n=125/187) and lumbar drains (n=22/187). Biochemically-confirmed CSF rhinorrhoea occurred in 6/159 (3.8%) TSA and 2/28 (7.1%) EEA. Four TSA (3%) and two EEA (7%) cases required operative management for CSF rhinorrhoea (CSF diversion or direct repair). Qualitative feedback was largely positive (themes included: user-friendly and efficient data collection, strong support from senior team members) demonstrating acceptability. Conclusions Our pilot experience highlights the acceptability and feasibility of CRANIAL. There is a precedent for multicentre dissemination of this project, in order to establish a benchmark of contemporary skull base neurosurgery practice, particularly with respect to EEA cases. Keywords Cerebrospinal fluid rhinorrhoeaCSFCerebrospinal fluid leakskull base surgeryendoscopic endonasalEE

CSF rhinorrhoea after endonasal intervention to the anterior skull base (CRANIAL): proposal for a prospective multicentre observational cohort study.

BACKGROUND: The endonasal transsphenoidal approach (TSA) has emerged as the preferred approach in order to treat pituitary adenoma and related sellar pathologies. The recently adopted expanded endonasal approach (EEA) has improved access to the ventral skull base whilst retaining the principles of minimally invasive surgery. Despite the advantages these approaches offer, cerebrospinal fluid (CSF) rhinorrhoea remains a common complication. There is currently a lack of comparative evidence to guide the best choice of skull base reconstruction, resulting in considerable heterogeneity of current practice. This study aims to determine: (1) the scope of the methods of skull base repair; and (2) the corresponding rates of postoperative CSF rhinorrhoea in contemporary neurosurgical practice in the UK and Ireland. METHODS: We will adopt a multicentre, prospective, observational cohort design. All neurosurgical units in the UK and Ireland performing the relevant surgeries (TSA and EEA) will be eligible to participate. Eligible cases will be prospectively recruited over 6 months with 6 months of postoperative follow-up. Data points collected will include: demographics, tumour characteristics, operative data), and postoperative outcomes. Primary outcomes include skull base repair technique and CSF rhinorrhoea (biochemically confirmed and/or requiring intervention) rates. Pooled data will be analysed using descriptive statistics. All skull base repair methods used and CSF leak rates for TSA and EEA will be compared against rates listed in the literature. ETHICS AND DISSEMINATION: Formal institutional ethical board review was not required owing to the nature of the study - this was confirmed with the Health Research Authority, UK. CONCLUSIONS: The need for this multicentre, prospective, observational study is highlighted by the relative paucity of literature and the resultant lack of consensus on the topic. It is hoped that the results will give insight into contemporary practice in the UK and Ireland and will inform future studies

CSF rhinorrhoea after endonasal intervention to the skull base (CRANIAL): A multicentre prospective observational study

ObjectiveDespite progress in endonasal skull-base neurosurgery, cerebrospinal fluid (CSF) rhinorrhoea remains common and significant. The CRANIAL study sought to determine 1) the scope of skull-base repair methods used, and 2) corresponding rates of postoperative CSF rhinorrhoea in the endonasal transsphenoidal approach (TSA) and the expanded endonasal approach (EEA) for skull-base tumors.MethodsA prospective observational cohort study of 30 centres performing endonasal skull-base neurosurgery in the UK and Ireland (representing 91% of adult units). Patients were identified for 6 months and followed up for 6 months. Data collection and analysis was guided by our published protocol and pilot studies. Descriptive statistics, univariate and multivariable logistic regression models were used for analysis.ResultsA total of 866 patients were included - 726 TSA (84%) and 140 EEA (16%). There was significant heterogeneity in repair protocols across centres. In TSA cases, nasal packing (519/726, 72%), tissue glues (474/726, 65%) and hemostatic agents (439/726, 61%) were the most common skull base repair techniques. Comparatively, pedicled flaps (90/140, 64%), CSF diversion (38/140, 27%), buttresses (17/140, 12%) and gasket sealing (11/140, 9%) were more commonly used in EEA cases. CSF rhinorrhoea (biochemically confirmed or requiring re-operation) occurred in 3.9% of TSA (28/726) and 7.1% of EEA (10/140) cases. A significant number of patients with CSF rhinorrhoea (15/38, 39%) occurred when no intraoperative CSF leak was reported. On multivariate analysis, there may be marginal benefits with using tissue glues in TSA (OR: 0.2, CI: 0.1-0.7, p&amp;lt;0.01), but no other technique reached significance. There was evidence that certain characteristics make CSF rhinorrhoea more likely – such as previous endonasal surgery and the presence of intraoperative CSF leak.ConclusionsThere is a wide range of skull base repair techniques used across centres. Overall, CSF rhinorrhoea rates across the UK and Ireland are lower than generally reported in the literature. A large proportion of postoperative leaks occurred in the context of occult intraoperative CSF leaks, and decisions for universal sellar repairs should consider the risks and cost-effectiveness of repair strategies. Future work could include longer-term, higher-volume studies, such as a registry; and high-quality interventional studies.</jats:sec