The aim of this study is to identify predictive factors for the outcome of gastro-esophageal reflux disease after gastric banding. Another aim is to identify predictive factors for the development of dysphagia.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of reflux complaints after gastric banding (increase, steady state
or decrease)
Outcome parameters:
- esophageal motility (assessed with high resolution manometry)
- reflux characteristics (assessed with pH/impedance monitoring)
- endoscopic findings (assessed with gastroscopy)
Secondary outcome
Esophageal motility: LES pressure, % peristaltic contractions, mean contractile
amplitude
pH/impedance monitoring: % reflux/24 h, frequention reflux episodes, acid or
non-acid, gaseous or liquid)
Patient characteristics: decrease BMI, waist circumference
Background summary
Laparoscopic adjustable gastric banding is now a usual method in the surgery of
obesity. Apart from the weight reduction effect even after long-term follow-up,
the band can interfere with esophageal function in a negative way, causing
dysmotility and reflux disease, especially in patients with reflux complaints
before gastric banding.
In this study subjects with pre-existing reflux complaints will be analyzed
with different techniques before and twelve months after gastric banding. It is
important to evaluate patients with reflux complaints before band placement,
because these subjects are more suscepitible for an aggravation of their reflux
disease or dysphagia after band placement.
Study objective
The aim of this study is to identify predictive factors for the outcome of
gastro-esophageal reflux disease after gastric banding. Another aim is to
identify predictive factors for the development of dysphagia.
Study design
In a prospective follow-up study the subject will undergo an assessment of
their reflux complaints before gastric banding, using questionnaires, high
resolution manometry and pH/impedance monitoring and gastroscopy. Twelve months
after band placement gastro-esophageal reflux complaints will be re-evaluated.
Dysphagia after gastric banding will be taken into account.
Study burden and risks
Specific for this study project:
On two moments patients were assessed with functional esophageal research. A
manometer probe and a thinner pH/impedance probe are introduced nasally. This
procedure has a minimal risk of aspiration, vasovagal collaps or nasal
bleeding. After 3 hours, the manometric probe is removed, and the patients
leaves the hospital with the 24 hour measurment probe. He/she has to count with
this probe in his daily activities
Risk other procedures in context of this project:
Laparoscopic gastric band placement is carried out, with the belonging risks of
anesthetic procedures and trombotic events. In obese subjects extra
precautionary measures were made.
The patients do also undergo a gastroscopy two times (an endoscopic evaluation
is part of standard care in patients willing bariatric surgery)
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- BMI > 40 or > 35 kg/m2 with obesity related comorbidity
- Reflux complaints (assessed with Reflux Disease Questionnaire)
- Positive screening in Nederlandse Obesitas Kliniek for laparoscopic gastric band placement
Exclusion criteria
- Severly disordered esophageal motility (<20 mmHg mean contraction amplitude in het lower esophagus and less than 50% peristaltic contractions)
- Unability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
- Endocrine disease causing overweight (hypothyroidism, hypercortisolism)
- Binge-eating disorder or associated eating disorders
- Active 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 | NL27746.041.09 |