No registrations found.
ID
Source
Brief title
Health condition
Inability to belch
Sponsors and support
Intervention
Outcome measures
Primary outcome
the ability of UES relaxation in response to esophageal distention caused by ingested air as assessed with stationary high-resolution impedance manometry
Secondary outcome
- To evaluate the number and type of belches, their association with reported symptoms and underlying mechanism as assessed with ambulatory 24-h impedance pH-monitoring.
- To identify the number of transient lower esophageal relaxations (TLESRs)
- To identify secondary peristalsis in reaction to ingested air
- To assess esophageal motility, UES, and LES morphology (resting pressure, relaxation pressure, presence of hiatal hernia
- To evaluate quality of life and symptoms of patients before and after Botox treatment
- What is the role of aerofagia in patient with inability to belch?
Background summary
Inability to belch is a phenomenon of unknown aetiology. Patients may present with lifelong symptoms of chest pain and/or abdominal bloating. As the phenomenon is quite rare and barely described in literature, there are no current guidelines or supporting evidence for a standardized diagnostic or therapeutic approach in these patients. A recent study treated patients unable to belch with botulin toxin (botox) injection into the cricopharyngeus muscle. All patients were able to belch and reported symptom improvement after treatment, which might indicate a role of upper esophageal sphincter (UES) dysfunction. However, belching and underlying mechanisms have never been objectively investigated in a series of consecutive patients unable to belch. The aim of this study is to reveal the underlying physiological mechanisms associated with symptoms of inability to belch and to study the effect of UES botox injections on UES physiology.
Study objective
We hypothesize that patients with symptoms of inability to belch have ineffective UES relaxation in response to esophageal distention caused by air.
Study design
Baseline and <6 weeks >3 months post botox injections
Intervention
High-resolution impedance manomotry monitoring before the scheduled botox treatment
Inclusion criteria
- Written informed consent;
- Age above 18 years;
- Complains of inability to belch, for at least 3 months.
Exclusion criteria
- Previous treatment for inability to belch
- History of pharyngeal or esophagal surgery or malignancies
- Use of medication affecting esophageal motility
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8494 |
| Other | METC AMC : W19_307#19.365 |