The primary objective is to assess the effect of sleeve gastrectomy on esophageal acid exposure. Other objectives are to assess the effect of sleeve gastrectomy on motility parameters as LES pressure and esophageal peristalsis.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Reflux time / 24 h before and after LSG
Secondary outcome
- LES pressure before and after LSG
- Esophageal peristalsis before and after LSG
Background summary
Laparoscopic sleeve gastrectomy (LSG) has recently been introduced as a
stand-alone, restrictive bariatric surgery for morbidly obese patients. The
procedure leads to significant weight reduction. Despite this positive effect,
some patients develop dysphagia or gastroesophageal reflux postoperatively. The
pathogenesis of these problems is not completely understood. It has been
proposed that LSG has an adverse effect on the function of the lower esophageal
sphincter (LES) due to gastric resection at the angle of His, predisposing the
patient to postoperative reflux symptoms. To date, there are no studies of LES
function and esophageal motility before and after LSG in relation to assessment
of esophageal acid exposure (as measured with ph-metry).
Study objective
The primary objective is to assess the effect of sleeve gastrectomy on
esophageal acid exposure.
Other objectives are to assess the effect of sleeve gastrectomy on motility
parameters as LES pressure and esophageal peristalsis.
Study design
In a prospective study before and three months after LSG esophageal function
tests will be carried out.
Study burden and risks
Patients will undergo esophageal manometry and 24 pH-metry before and after
LSG. The risk associated with these procedures is limited.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Body mass index (BMI) >40 kg/m2 or BMI>35 kg/m2 with obesity related comorbidities
- Positive screening for sleeve gastrectomy
Exclusion criteria
- Binge-eating or associated eating disorder
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
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 | NL31649.060.10 |