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

Abstract

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

“…A multicenter prospective observational cohort study design was implemented 21 at 12 tertiary academic neurosurgical units where the CRANIAL network had previously been established: Aberdeen Royal Infirmary (Aberdeen, United Kingdom), Addenbrooke's Hospital (Cambridge, United Kingdom), Beaumont Hospital (Dublin, Ireland), Greater Manchester Neurosciences Centre (Salford, United Kingdom), John Radcliffe Hospital (Oxford, United Kingdom), National Hospital for Neurology and Neurosurgery (London, United Kingdom), Queen Elizabeth Hospital Birmingham (Birmingham, United Kingdom), Royal Hallamshire Hospital (Sheffield, United Kingdom), Royal Victoria Hospital (Belfast, United Kingdom), Royal Victoria Infirmary (Newcastle-upon-Tyne, United Kingdom), Sheffield Children's Hospital (Sheffield, United Kingdom), and the Walton Centre (Liverpool, United Kingdom). The project was registered as a service evaluation at each center, with approval received from the audit department of each institution (and Caldicott guardians when required).…”

“…The eligible cases included patients of all ages who had undergone the transsphenoidal approach (TSA) for sellar tumors or the expanded endonasal approach (EEA) for skull base tumors. 21 The exclusion criteria were transcranial surgery and a history of preoperative CSF rhinorrhea. Case selection was limited to patients who had presented from March 23 to July 31, 2020, inclusive.…”

“…The data points collected by medical students or junior trainees were confirmed with the operating surgeons or senior members of the team before final submission to the Castor Electronic Data Capture system. 21 …”

“…Data validation was performed in all centers to audit quantitative data accuracy. 21 This involved an independent data validator (who had not collected the local data) who reviewed the datasets for several enrolled cases, selected randomly. Each data validator was from the hospital in which the data had been collected.…”

“…These data are essential, especially to quantify the effects on those who have undergone an endonasal operation in the context of a respiratory virus. The timeline of a prospective multicenter pilot study in the United Kingdom and Republic of Ireland—CRANIAL (CSF [cerebrospinal fluid] rhinorrhea after endonasal intervention to the skull base) 21 —coincided with the start of the COVID-19 pandemic. This provided a unique opportunity to assess the effects of the COVID-19 pandemic on endonasal surgery practices in the United Kingdom in real time.…”