Define reference values for gastric and oesophageal scintigraphy for post-bariatric surgery patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas, bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objectives:
- to define reference values for gastric scintigraphy using an optimised
protocol (GE in T1/2 and retention);
- to define reference values for oesophageal scintigraphy using an optimised
protocol;
- to describe SPECT/CT images and determine its benefit for anatomical
correlation in asymptomatic (reference) and symptomatic population.
Secondary outcome
Secondary objectives:
- to explore the correlation of GE and oesophageal transit, and weight loss
results or symptoms, using prospective data from this study and retrospective
data from 53 symptomatic patients and similar studies previously (n=15,
patients with RYGB) or currently (n = 24, patients with sleeve gastrectomy)
performed in our centre, available for comparison.
Background summary
Oesophageal and gastric scintigraphy evaluates the function of the
gastrointestinal system including variables such as oesophageal transit and
gastric emptying (GE). Some variables are known to change after bariatric
surgery. In patients that have symptoms of pain or nausea after bariatric
surgery, oesophageal and gastric scintigraphy plays an important role in
determining the nature of symptoms and is necessary for adequate treatment.
However, literature on reference values in the bariatric population are scarce.
At this moment, quantitative evaluation of the scintigraphy cannot be performed
and conclusions are based on visual interpretation. There is a need for a
standardized scintigraphy protocol for the population that underwent bariatric
surgery taking into account the changed anatomy and physiology. Then, reference
values that describe the oesophageal transit and GE assessed using scintigraphy
have to be determined.
Study objective
Define reference values for gastric and oesophageal scintigraphy for
post-bariatric surgery patients.
Study design
In this prospective cross-sectional observational study, participants will
undergo oesophageal and gastric scintigraphy to define reference values for
post-bariatric surgery patients.
Study burden and risks
The radiation dose of scintigraphy is less than 0.3 mSv. The radiation dose of
SPECT/CT is about 1.5 mSv. For comparison, the average background radiation in
the Netherlands is 2.0 mSv per year and a transatlantic flight is 0.1 mSv. The
radiation burden of this investigation is a minor risk.
Participation in this study implies time investment of one hour to two hours,
and an extra visit to Rijnstate hospital Arnhem (although we try to plan the
study visit in Rijnstate Arnhem on the same day as the medical visit in
Rijnstate Elst to minimise time investments). There is no personal benefit for
the participants in this study. This study will result in better understanding
of GE after bariatric surgery. There are no special reservations for the used
measurements in patients with obesity. Following the risk classification of the
NFU, there is a negligible risk for participants of the study.
Eusebiusbuitensingel 20-6
Arnhem 6828HV
NL
Eusebiusbuitensingel 20-6
Arnhem 6828HV
NL
Listed location countries
Age
Inclusion criteria
- age between 18 and 65 years;
- a 2 to 3 year postoperative period after bariatric surgery (gastric sleeve or
Roux-and-Y bypass as primary surgery);
- an umcomplicated procedure, and without symptoms of pain/nausea/etc;
- normal weight loss (defined as total weight loss [TWL]: 25% < TWL < 35%).
Exclusion criteria
- Pre-existent oesophageal or gastric motility disorder, dysphagia, reflux,
(postprandial) abdominal pain, neurological or metabolic conditions that
significantly affect oesophageal or gastric motility;
- When using proton pump inhibitors (PPI) or H2-antagonists, the inability to
stop using them for 3 days;
- Using opioids;
- Previous oesophago-gastric surgery, other than bariatric surgery;
- Unable to stop smoking for 24h;
- Pregnancy or breast-feeding;
- Patients with a drug or alcohol addiction.
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 | NL85795.091.23 |