Bariatric Surgery, Gastric Emptying
Conditions
Keywords
Gastric emptying, Gastric sleeve, MRI, Scintigraphy
Brief summary
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.
Detailed description
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.
Interventions
OTHERMRI and scintigraphy
Gastric emptying measured with MRI and scintigraphy
Sponsors
Rijnstate Hospital
Wageningen University and Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Inclusion criteria
* 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
Exclusion criteria
* 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 24h * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying compared between patients with poor and successful weight loss | 2-3 years | Gastric emptying (T1/2 \[min\] and retention \[%/min\]) |
| Gastric emptying compared between measured with MRI and scintigraphy | 2-3 years | Gastric emptying (T1/2 \[min\] and retention \[%/min\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss | 2-3 years | Volume (sleeve size \[mL\] and gastric acid \[mL\]) |
| to assess the association between gastric emptying rate and gastric sleeve characteristics in each group | 2-3 years | association between outcome 1, 2 and 3 |
| to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss | 2-3 years | questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test) |
Countries
Netherlands
Outcome results
None listed