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

Abstract

IntroductionEffective 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 35 kg/m2. The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m2 and a qualifying comorbidity; currently IIH does not qualify as a comorbidity.Methods and analysisIIH:WT is a multicentre, open-label, randomised controlled clinical trial of 64 participants with active IIH and a BMI over 35 kg/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 numberIIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage.

What are the research priorities for idiopathic intracranial hypertension? A priority setting partnership between patients and healthcare professionals

“…The 2015 Cochrane review concluded that there is a lack of evidence to guide pharmacological treatment 2. There are a few published randomised clinical trials3 4 and a small number of ongoing trials 5 6. Research is infrequent due to the rarity of the IIH7 8 and the lack of understanding of the underlying pathology 9…”

Bariatric Surgery as a Treatment for Idiopathic Intracranial Hypertension in a Male Adolescent: Case Report

“…11 A prospective randomized trial in adults is currently evaluating its effectiveness. 12 There is a paucity of evidence-based recommendations for the treatment of IIH in children or adolescents. 1 According to the International and the Brazilian Guidelines, adolescents with a BMI greater than 35 kg/m 2 , associated with severe comorbidities and complete growth plate (epiphyseal cartilage) closure, may clinically benefit from surgical weight loss.…”

<p>Exploring The Current Management Idiopathic Intracranial Hypertension, And Understanding The Role Of Dural Venous Sinus Stenting</p>

“…For example, a prospective study 21 has demonstrated that a very low-calorie diet resulting in significant weight loss (15.3±7.0% of body weight) significantly lowered ICP and led to a significant improvement in papilloedema, vision and headache outcomes. There is an ongoing multicentre, randomised controlled trial 22 designed to assess if weight loss through bariatric surgery is a more effective sustainable treatment for IIH than lifestyle modification through a community weight management program.…”