Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma - protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial.

INTRODUCTION: The top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was 'Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people diagnosed with a cavernoma?' This pilot randomised controlled trial (RCT) aims to determine the feasibility of answering this question in a main phase RCT. METHODS AND ANALYSIS: We will perform a pilot phase, parallel group, pragmatic RCT involving approximately 60 children or adults with mental capacity, resident in the UK or Ireland, with an unresected symptomatic brain cavernoma. Participants will be randomised by web-based randomisation 1:1 to treatment with medical management and with surgery (neurosurgery or stereotactic radiosurgery) versus medical management alone, stratified by prerandomisation preference for type of surgery. In addition to 13 feasibility outcomes, the primary clinical outcome is symptomatic intracranial haemorrhage or new persistent/progressive focal neurological deficit measured at 6 monthly intervals. An integrated QuinteT Recruitment Intervention (QRI) evaluates screening logs, audio recordings of recruitment discussions, and interviews with recruiters and patients/parents/carers to identify and address barriers to participation. A Patient Advisory Group has codesigned the study and will oversee its progress. ETHICS AND DISSEMINATION: This study was approved by the Yorkshire and The Humber-Leeds East Research Ethics Committee (21/YH/0046). We will submit manuscripts to peer-reviewed journals, describing the findings of the QRI and the Cavernomas: A Randomised Evaluation (CARE) pilot trial. We will present at national specialty meetings. We will disseminate a plain English summary of the findings of the CARE pilot trial to participants and public audiences with input from, and acknowledgement of, the Patient Advisory Group. TRIAL REGISTRATION NUMBER: ISRCTN41647111.

Surgical decompressions for cauda equina syndrome during COVID-19.

BACKGROUND: The novel coronarvirus disease (COVID-19) has had a major impact on provision of spinal neurosurgery across the world, especially in the UK, with a significant fall in operating and patient volumes, and elective clinical activities. It is unclear whether the pandemic has affected the volume of urgent spinal procedures in the UK, especially surgical decompressions for cauda equina syndrome (CES). METHODS: Therefore, we conducted a retrospective analysis of theatre records and electronic operation notes at our institution to identify all procedures performed for CES before (December 2019 to February 2020) and during (March 2020 to May 2020) the COVID-19 pandemic. Statistical analyses were performed on SPSS v22 (IBM). RESULTS: Forty-four patients underwent surgical decompressions during the study period. Over half (54.5%) were female and the median age was 45 years (range = 22-78 years). Three in four procedures were performed at L4-5 and L5-S1 levels (79.5%). There was no statistically significant difference in the number of decompressions performed each month [χ2(5)=1.818; p = 0.874]. On the other hand, the number of referrals for suspected or confirmed CES fell by 81.8% between December 2019 and April 2020. CONCLUSIONS: Our results did not show any statistically significant decline in the volume of surgical decompressions performed for CES despite the considerable fall in electronic referrals for CES and degenerative spinal conditions. This suggests that patients with critical neurological symptoms continued to present and were treated appropriately despite the restrictions imposed on spinal surgeons during the pandemic.