Gastric Emptying measured with MRI and Scintigraphy in patients with successful versus unsuccessful weight loss after Sleeve gastrectomy
- Conditions
- Bariatrische chirurgiemaagontledigingobesitasBariatisc surgeryobesity
- Registration Number
- NL-OMON49419
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
- Women aged between 20 and 55 years who underwent sleeve gastrectomy as
primary procedure with either TWL < 25% or TWL > 35%.
- Patients who had a follow-up period of 2-3 years after sleeve gastrectomy
- Maximum BMI >50 kg/m2
- Patients with a disease known to affect appetite, gastric emptying or
gastrointestinal motility
- Patients who are unable to stop medications that affect gastric emptying
and/or motility prior to measurements. It is depending on t1/2 for how long
they need to stop medication.
- Patients who started menopause
- Patients with gastrointestinal problems or, gastric or intestinal diseases
- Patients with a drug or alcohol addiction
- Patients who are unable to stop smoking for 24 hours
- Patients who are pregnant or lactating
- Patients who have an intolerance or allergy for one of the components of the
test product
- Patients who have a contra-indication to MRI scanning
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objectives:<br /><br>1. To compare gastric emptying rate between patients with successful and<br /><br>unsuccessful weight loss two years after sleeve gastrectomy.<br /><br>2. To compare gastric emptying rate as measured with MRI to gastric emptying<br /><br>rate measured with scintigraphy</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br>1. To compare sleeve characteristics between patients with successful and<br /><br>unsuccessful weight loss<br /><br>2. Assess the association between gastric emptying rate and gastric sleeve<br /><br>characteristics in each group.<br /><br>3. To compare subjective ratings of gastric fullness and wellbeing between<br /><br>patients with successful and unsuccessful weight loss. </p><br>