UK Chiari 1 Study
Research type
Research Study
Full title
UK Chiari 1 Study
IRAS ID
269739
Contact name
Shahista Hussain
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
PID14531, Sponsor Ref Number
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
BACKGROUND
Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by herniation of the cerebellar tonsils through the foramen magnum. The management of CM1 remains contentious since there are currently no UK guidelines. Practice varies widely between neurosurgical units and individual surgeons, but there is no robust evidence to bring consensus to the selection of surgical candidates or to the specific surgical technique for CM1. We therefore propose a collaborative, prospective, multi-centre study on the investigation, management and outcome of CM1 in the UK.OBJECTIVES
Our primary objective is to determine the patient/parent-reported, health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months follow up. This will be measured using the 36-Item Short Form Health Survey in adults (16 years and above) and the age-appropriate parent-reported Pediatric Quality of Life Inventory in children (2 to 15 years). We also aim to i) assess the scope and variation of contemporary investigations and neurosurgical management for CM1 in the UK; ii) determine factors that are predictive of postoperative outcome; iii) to examine the outcomes of varying surgical strategies (including HRQoL 12-following decompressive surgery); and iv) to investigate the natural history of patients managed conservatively.METHODS
The UK Chiari 1 Study will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative (BNTRC) model of collaborative research. Patients will be recruited after attending their first neurosurgical clinic and afterwards collect data of all patients undergoing foramen magnum decompression (FMD), other surgery or being treated conservatively for CM1 in participating UK neurosurgical units. Data will be both patient/parent-reported (via digital questionnaires) and surgeon-reported. Each participating site will complete the study within three years.The study is funded by the Ann Conroy Trust.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0053
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion