Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol

Ottridge, Ryan; Mollan, Susan P; Botfield, Hannah; Frew, Emma; Ives, Natalie J; Matthews, Tim; Mitchell, James; Rick, Caroline; Singhal, Rishi; Woolley, Rebecca; Sinclair, Alexandra J

Abstract

Introduction: Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass index (BMI) have been shown to lower ICP and improve symptoms in IIH; however, weight loss is typically not maintained, meaning IIH symptoms return. The Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) will assess whether bariatric surgery is an effective long-term treatment for patients with IIH with a BMI over 35kg/m2. The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35kg/m2 and a qualifying comorbidity; currently IIH does not qualify as a comorbidity.

Methods and analysis: IIH:WT is a multicentre, open-label, randomised controlled clinical trial of 64 participants with active IIH and a BMI over 35kg/m2. Participants will be randomised in a 1:1 ratio to bariatric surgery or a dietary weight loss programme and followed up for 5 years. The primary outcome measure is ICP at 12 months. Secondary outcome measures include ICP at 24 and 60 months, and IIH symptoms, visual function, papilloedema, headache, quality of life and cost-effectiveness at 12, 24 and 60 months.

Trial registration number IIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage.

Citation

Ottridge, R., Mollan, S. P., Botfield, H., Frew, E., Ives, N. J., Matthews, T., …Sinclair, A. J. (2017). Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open, 7(9), 1-8. https://doi.org/10.1136/bmjopen-2017-017426

• Journal Article Type: Article
• Acceptance Date: Aug 7, 2017
• Online Publication Date: Sep 27, 2017
• Publication Date: 2017-09
• Deposit Date: Jun 27, 2019
• Publicly Available Date: Jul 2, 2019
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 7
• Issue: 9
• Article Number: e017426
• Pages: 1-8
• DOI: https://doi.org/10.1136/bmjopen-2017-017426
• Public URL: https://nottingham-repository.worktribe.com/output/2235659
• Publisher URL: https://bmjopen.bmj.com/content/7/9/e017426