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.
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.
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DOI：
10.1136/bmjopen-2017-017426
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发表时间：
2017-09-27
期刊：
影响因子：
2.9
通讯作者：
Sinclair AJ
中科院分区：
文献类型：
--
作者：
Ottridge R;Mollan SP;Botfield H;Frew E;Ives NJ;Matthews T;Mitchell J;Rick C;Singhal R;Woolley R;Sinclair AJ
特发性颅内高压（IIH）缺乏有效的治疗方法，这是一种以颅内压升高（ICP）和视乳头水肿为特征的疾病，主要见于肥胖女性。体重减轻和降低体重指数（BMI）已被证明可以降低ICP并改善IIH的症状;然而，体重减轻通常不会维持，这意味着IIH症状会复发。特发性颅内高血压体重试验（IIH：WT）将评估减肥手术是否是BMI超过35 kg/m2的IIH患者的有效长期治疗方法。国家健康与护理卓越研究所建议BMI超过35 kg/m2且符合条件的合并症患者进行减肥手术;目前IIH不符合合并症的条件。IIH：WT是一项多中心、开放标签、随机对照临床试验，纳入了64例活动性IIH和BMI超过35 kg/m2的受试者。参与者将以1：1的比例随机分配到减肥手术或饮食减肥计划，并随访5年。主要结局指标是12个月时的ICP。次要结局指标包括24个月和60个月时的ICP，以及12个月、24个月和60个月时的IIH症状、视功能、视乳头水肿、头痛、生活质量和成本效益。IIH：WT注册为ISRCTN 40152829，在ClinicalTrials.gov上注册为NCT 02124486，目前处于预结果阶段。
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/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. IIH: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. IIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage.
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影响因子：
3.5
作者：
Celebisoy, N.;Goekcay, F.;Akyuerekli, Oe.
通讯作者：
Akyuerekli, Oe.
DOI：
10.1136/bmj.g3961
发表时间：
2014-08-27
期刊：
BMJ (Clinical research ed.)
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13.7
作者：
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作者：
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