To assess PE rate and pouch characteristics in good and bad responders two years after LRYGB by MRI.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
obesitas, bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: PE rate two years after LRYGB, pouch characteristics; extended pouch
width and pouch outlet diameter.
Secondary outcome
Secondary: subjective ratings of fullness and wellbeing.
Background summary
One of the most performed type of bariatric surgery in the Netherlands is the
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). However, LRYGB is not effective
in all bariatric patients, around 10% to 15% of bariatric patients have
insignificant WL. The exact physiological mechanisms behind this individual
variation are unknown. In several studies, the pouch emptying (PE) rate has
been suggested as an important factor related to the successfulness of WL after
LRYGB.
However, studies regarding PE and WL showed contradictive results; one pilot
study found that patients with poor WL (bad responders) showed greater PE,
opposing to one study which showed greater PE in successful WL patients (good
responders), and one study that showed normal PE in good responders and slower
PE in bad responders. Thus, more research regarding the relation between PE and
weight loss in LRYGB patients is needed.
PE rate can be measured with scintigraphy (SG). However, magnetic resonance
imaging (MRI) does not use harmful gamma radiation and provides more detailed
anatomical information, which can be useful to detect differences in PE rate
but also pouch characteristics such as its diameter. Such characteristics may
explain differences in PE rate.
We hypothesize that PE rate is greater in bad responders in terms of WL
compared to good responders after LRYGB. Additionally, we hypothesize that
pouch characteristics, such as extended pouch width and pouch outlet diameter,
differ between good and bad responders after LRYGB.
Study objective
To assess PE rate and pouch characteristics in good and bad responders two
years after LRYGB by MRI.
Study design
A cross-sectional observational study in which PE rate, extended pouch width
and pouch outlet diameter are measured with MRI in good and bad responders two
years after LRYGB.
Study burden and risks
Patients will be asked to fast overnight and undergo a 90-min MRI scanning
session after ingestion of 125 gram of a semi-solid food. They will also rate
their fullness and wellbeing at baseline and after each gastric MRI scan. These
measurements are non-invasive and carry minimal risk. The study is
non-therapeutic.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- Women aged between 20 and 55 years
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent (IC) prior to any study procedures
- Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
- Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician
Exclusion criteria
- Diabetes Mellitus
- Menopausal
- Gastrointestinal problems, gastric or intestinal diseases
- Drug or alcohol addiction
- Inability to stop smoking during the overnight fasting period
- Pregnant or lactating
- Having an intolerance or allergy for one of the components of the test product
- Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Having a contra-indication to MRI scanning (including, but not limited to):
o Pacemakers and defibrillators
o Intraorbital or intraocular metallic fragments
o Ferromagnetic implants
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 |
|---|---|
| ClinicalTrials.gov | NCT02539641 |
| CCMO | NL67969.091.18 |