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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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5623580/
https://www.ncbi.nlm.nih.gov/pubmed/28963303
http://dx.doi.org/10.1136/bmjopen-2017-017426
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author 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
author_facet 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
author_sort Ottridge, Ryan
collection PubMed
description 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 35 kg/m(2). The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m(2) 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 35 kg/m(2). 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.
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spelling pubmed-56235802017-10-10 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 BMJ Open Neurology 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 35 kg/m(2). The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m(2) 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 35 kg/m(2). 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. BMJ Publishing Group 2017-09-27 /pmc/articles/PMC5623580/ /pubmed/28963303 http://dx.doi.org/10.1136/bmjopen-2017-017426 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Neurology
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5623580/
https://www.ncbi.nlm.nih.gov/pubmed/28963303
http://dx.doi.org/10.1136/bmjopen-2017-017426
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