Bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertensio
- Conditions
- Idiopathic Intracranial Hypertension (IIH) - neurology, neuro-ophthalmology.Nervous System DiseasesBenign intracranial hypertension
- Registration Number
- ISRCTN40152829
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28963303/ (added 22/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34420064/ Sub-study results (added 23/08/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35790425/ (added 06/07/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 66
1. Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (> 2 months duration), active disease (visual impairment, papilloedema, significantly raised ICP > 25 cmH2O) and normal brain imaging (magnetic resonance imaging and venography as noted at diagnosis)
2. Body mass index (BMI) >35 kg/m2
3. Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months
4. Able to give informed consent
Original exclusion criteria:
1. Age less than 18 or older than 55 years
2. Pregnant
3. Significant co-morbidity, endocrinopathy or the use of hormone-manipulating medication
4. Undergone optic nerve sheath fenestration
5. Definite indication for or contraindication against surgery or dieting
6. Have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method