Khan Danyal Z, Bandyopadhyay Soham, Patel Vikesh, Schroeder Benjamin E, Cabrilo Ivan, Choi David, Cudlip Simon A, Donnelly Neil, Dorward Neil L, Fountain Daniel M, Grieve Joan, Halliday Jane, Kolias Angelos G, Mannion Richard J, O'Donnell Alice, Phillips Nick, Piper Rory J, Ramachandran Bhavna, Santarius Thomas, Sayal Parag, Sharma Rishi, Solomou Georgios, Tysome James R, Marcus Hani J, Alalade Andrew F, Ahmed Shahzada, Al-Barazi Sinan, Al-Mahfoudh Rafid, Bahl Anuj, Bennett David, Bhalla Raj, Bhatt Pragnesh, Dow Graham, Giamouriadis Anastasios, Gilkes Catherine, Gnanalingham Kanna, Hanna Brendan, Hayhurst Caroline, Hempenstall Jonathan, Hossain-Ibrahim Kismet, Hughes Mark, Javadpour Mohsen, Jenkins Alistair, Kamel Mahmoud, Habibullah Khan Mohammad, Lacy Peter, Maratos Eleni, Martin Andrew, Mathad Nijaguna, Mendoza Nigel, Mirza Showkat, Muquit Sam, Nair Ramesh, Nicholson Claire, Paluzzi Alex, Paraskevopoulos Dimitris, Pathmanaban Omar, Pollock Jonathan, Ram Bhaskar, Robertson Iain, Ross Peter, Shaw Simon, Shoakazemi Alireza, Sinha Saurabh, Stapleton Simon, Statham Patrick, Stew Benjamin, Thomas Nick, Tsermoulas Georgios, Weir Philip, Williams Adam
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge and Cambridge University Hospitals Trust, Cambridge, UK.
Medical Sciences Division, University of Oxford, Oxford, UK.
Br J Neurosurg. 2021 Aug;35(4):408-417. doi: 10.1080/02688697.2020.1795622. Epub 2020 Sep 10.
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.
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.
Formal institutional ethical board review was not required owing to the nature of the study - this was confirmed with the Health Research Authority, UK.
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.
经鼻蝶窦入路（TSA）已成为治疗垂体腺瘤及相关鞍区病变的首选入路。最近采用的扩大经鼻入路（EEA）在保留微创手术原则的同时，改善了对颅底腹侧的显露。尽管这些入路具有诸多优势，但脑脊液鼻漏仍是一种常见的并发症。目前缺乏比较性证据来指导颅底重建的最佳选择，导致当前的实践存在很大差异。本研究旨在确定：（1）颅底修复方法的范围；（2）在英国和爱尔兰当代神经外科实践中术后脑脊液鼻漏的相应发生率。
我们将采用多中心、前瞻性、观察性队列设计。英国和爱尔兰所有进行相关手术（TSA和EEA）的神经外科单位均有资格参与。符合条件的病例将在6个月内前瞻性招募，并进行6个月的术后随访。收集的数据点将包括：人口统计学、肿瘤特征、手术数据以及术后结果。主要结局包括颅底修复技术和脑脊液鼻漏（经生化证实和/或需要干预）的发生率。汇总数据将采用描述性统计进行分析。将所有使用的颅底修复方法以及TSA和EEA的脑脊液漏发生率与文献中列出的发生率进行比较。
由于研究的性质，无需进行正式的机构伦理委员会审查——英国健康研究管理局已确认此事。
相对较少的文献以及由此导致的该主题缺乏共识凸显了进行这项多中心、前瞻性、观察性研究的必要性。希望研究结果能深入了解英国和爱尔兰的当代实践，并为未来的研究提供参考。
