To assess the relationship between postprandial symptoms and gastric emptying rate. The caloric intake and caloric gastric emptying rate in the pathogenesis of postprandial symptoms after sleeve gastrectomy will also be taken into account
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- postprandial symptoms and food intolerance (scored with a validated
questionnaire) after sleeve gastrectomy;
- gastric emptying after sleeve gastrectomy;
Secondary outcome
- caloric emptying rate (cal/min
- PPI dependence 12 months after sleeve gastrectomy
Background summary
A sleeve gastrectomy as a stand alone procedure is a relatively new but
promising bariatric surgical procedure to treat morbidly obese patients.
However, the clinical experience is that postprandial symptoms - to be more
precise: symptoms of gastroesophageal reflux and dyspepsia - compromise the
beneficial effect of this operation in a considerable proportion of these
patients.
Earlier studies have shown that gastric emptying is accelerated for liquids and
solids in patients after sleeve gastrectomy. It is not known if gastric
emptying or caloric emptying rate is changed in the patients with postprandial
symptoms as compared to patients without these complaints.
We hypothesize that the caloric emptying rate will be an important factor in
the group of patients with postprandial symptoms en may be independent from the
reduced caloric intake in explaining the post-surgical weight loss. The
relationship between caloric intake and caloric emptying rate was not studied
before.
Study objective
To assess the relationship between postprandial symptoms and gastric emptying
rate. The caloric intake and caloric gastric emptying rate in the pathogenesis
of postprandial symptoms after sleeve gastrectomy will also be taken into
account
Study design
In patients with and without postprandial symptoms a gastric emptying study
with solid and liquid food will be carried out 12 months after the sleeve
gastrectomy
Study burden and risks
Patients will undergo a gastric emptying study postoperatively. The scientific
benefits of our study outweigh the nucleair radiation burden (0.49 mSv) of this
assessment.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
Exclusion criteria
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism)
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 | NL40305.060.12 |