To assess and compare the gastric emptying rate and gut hormone levels between patients one year after standard RYGB (S-RYGB), B-RYGB and EP-RYGB.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric emptying rate and gut hormone levels in patients one year after S-RYGB,
B-RYGB and EP-RYGB.
Secondary outcome
Excess weight loss (%EWL)
Background summary
The most performed type of bariatric surgery performed in Europe is de the
Roux-en-Y gastric bypass (RYGB). It*s an effective treatment of morbid obesity,
with long-term weight loss and improvement of obesity related comorbidities.
The mechanisms that are involved remain not fully understood. After RYGB the
stomach volume is decreased and satiety levels often increase probably due to
changes in gut hormones. Gastric emptying is often mentioned as mechanism
effecting weight loss by its role in the release of these hormones. A fast
pouch emptying in patients with poor weight loss after RYGB is found.
To improve the short and long term weight loss after RYGB the technique of the
operation is modified and studied. Banding of the gastric pouch (B-RYGB) and
creating a longer and narrower pouch, an extended pouch RYGB (EP-RYGB) may,
following physical laws, delay pouch emptying resulting in more weight loss
after surgery. The more gradual emptying may induce a longer period of gut
hormone secretion and therefore increase satiety.
Study objective
To assess and compare the gastric emptying rate and gut hormone levels between
patients one year after standard RYGB (S-RYGB), B-RYGB and EP-RYGB.
Study design
A prospective trial in which gastric emptying rate an gut hormone levels are
measured in patients one year after S-RYGB, B-RYGB and EP-RYGB.
Study burden and risks
Participation in this study implies extra visits to the participating hospital.
The absorbed effective dose equivalent of radiation falls into the lowest risk
category.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Patient underwent a standard RYGB (S-RYGB), B-RYGB or EP-RYGB and is a mean responder (clinic mean Excess Weight Loss +/- 10% or mean Total Body Weight Loss +/- 5%).
- Patient is able to adhere to the study visit schedule and protocol requirements
- Patient is able to give informed consent and the consent must be obtained prior to any study procedures
- Patient had a follow-up period of at least one year after S-RYGB, B-RYGB or EP-RYGB without any complications
Exclusion criteria
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Pregnancy and when giving breast feeding
- Gluten allergy
- 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 | NL62399.091.17 |