The aim of this study is to identify predictive factors for the outcome of gastro-esophageal 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 identification of predictive factors in the pattern of reflux complaints
and impaired esophageal transit before and after gastric banding, as measured
with manometry and pH/impedance monitoring. Therefore, patients in which reflux
complaints decrease, increase or stay unchanged postoperatively will be
compared with each other.
Secondary outcome
- LES pressure
- % reflux / 24 hours
- Body Mass Index
- Waist Circumference
Background summary
Laparoscopic adjustable gastric banding is nowadays a usual method in the
surgical treatment of obesity. Apart from the weight reduction effect even
after long-term follow-up, it can interfere with esophageal function in a
negative way, causing dysmotility or 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 after laparoscopic adjustable gastric banding. It is important to
evaluate patients with reflux complaints before band placement, because these
subjects are susceptible for reflux disease or dysphagia after band placement.
Pathologic findings can be a contraindication for gastric banding.
Study objective
The aim of this study is to identify predictive factors for the outcome of
gastro-esophageal 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 subjects will undergo an assessment of
their reflux complaints before gastric banding, using gastroscopy, esophageal
manometry an pH/impedance monitoring and two validated questionnaires. Twelve
months after band placement gastroesophageal reflux complaints will be
re-evaluated. Dysfagia after gastric banding will be taken into account.
Study burden and risks
Participation is this study implies visits to the UMC Utrecht. Before and after
gastric banding with an interval of at least twelve months, esophageal
manometry and pH/impedance monitoring will be carried out in this patients. The
risk associated with these procedures is limited.
Preoperatively it's important to identify hiatus hernia and reflux esophagitis.
This ailments can be repaired surgically or treated with medication
respectively. Hence a gastroscopy is carried out before gastric band placement.
Twelve months after band placement a gastroscopy is repeated. It's particularly
important to do this, since the number of patients who develop an esophagitis
after band placement can not be neglected [Suter et al., Arch Surg 2005].
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- BMI > 40 or BMI > 35 with comorbidity
- Reflux complaints (RDQ > 0)
- Positive screening in Nederlandse Obesitas Kliniek for laparoscopic gastric band placement
Exclusion criteria
- Severly disordered esophageal motility ( < 20 mmHg mean contraction amplitude in the lower esophagus and less than 50% peristaltic contractions)
- 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
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25379.041.09 |