To assess gastric emptying (GE) with MRI in patients with successful versus unsuccessful weight loss after gastric sleeve surgery and compare with gastric emptying as measured with the more frequently used scintigraphy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Bariatrische chirurgie; maagontlediging; obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objectives:
1. To compare gastric emptying rate between patients with successful and
unsuccessful weight loss two years after sleeve gastrectomy.
2. To compare gastric emptying rate as measured with MRI to gastric emptying
rate measured with scintigraphy
Secondary outcome
Secondary objectives:
1. To compare sleeve characteristics between patients with successful and
unsuccessful weight loss
2. Assess the association between gastric emptying rate and gastric sleeve
characteristics in each group.
3. To compare subjective ratings of gastric fullness and wellbeing between
patients with successful and unsuccessful weight loss.
Background summary
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%), we may obtain better
insight in the aetiology of weight loss after sleeve gastrectomy. We will
measure GE 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.
Study objective
To assess gastric emptying (GE) with MRI in patients with successful versus
unsuccessful weight loss after gastric sleeve surgery and compare with gastric
emptying as measured with the more frequently used scintigraphy.
Study design
A cross-sectional observational study in which GE rate, gastric sleeve width,
gastric sleeve outlet diameter and gastric motility are measured during two
study visits, one visit GE is measured with MRI and the other visit with
scintigraphy, in patients with successful versus unsuccessful weight loss two
to three years after gastric sleeve surgery.
Study burden and risks
Patients will be asked to undergo both a MRI and gastric scintigraphy session
within a four week period, after a minimum of 4 hours fasting. Patients undergo
a 60-min MRI and gastric scintigraphy scanning session after ingestion of 125
gram of a semi-solid food. Imaging measurements will be performed at baseline
and every 10 min after ingestion up to t=60 minutes. After each measurement
participants will rate fullness, bloating, satiety and wellbeing. These
measurements are non-invasive and carry minimal risk. The study is
non-therapeutic.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
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 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74432.091.20 |