The first aim of this study is to identify factors which predict an improvement of gastroesophageal reflux after gastric banding. The second aim is to assess the effect of gastric banding on gastroesophageal reflux after the operation.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Change in reflux symptoms before and 12 months after gastric banding
Outcome parameter: Reflux disease questionnaire (RDQ) score
Secondary outcome
- Change in esophageal reflux parameters before and 12 months after gastric
banding
Outcome parameters:
- esophageal motility (LES pressure, percentage peristaltic contractions)
- refluxtime (percentage of time with pH<4) during 24 hours.
- endoscopic findings
- Development of dysphagia after gastric banding
Outcome parameter: QLQ-OES 24 dysphagia score
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 will be analyzed who are eligible for gastric band
placement. Those with pre-existing reflux complaints will be asked to
participate in this study. They will be assessed 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 after band
placement.
Study objective
The first aim of this study is to identify factors which predict an improvement
of gastroesophageal reflux after gastric banding.
The second aim is to assess the effect of gastric banding on gastroesophageal
reflux after the operation.
Study design
In a prospective follow-up study the subjects will undergo an assessment of
their reflux disease 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.
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
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29877.041.09 |