Anti-reflux mucosectomy (ARMS) for gastroesophageal reflux disease: efficacy and mechanism of actio
- Conditions
- Reflux disease
- Registration Number
- NL-OMON28707
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
Indication for surgical treatment, defined by objectively confirmed gastroesophageal reflux disease (24-h ambulatory pH-impedance study with a symptom association probability =95%; and esophageal acid exposure =4%)
- Symptoms of heartburn, regurgitation and/or chest pain under PPI-treatment for at least 3 months at least 3 times a week.
- Use of proton pump inhibitors at a standard dose twice a day for at least 4 weeks prior to inclusion.
- ASA classification of III or higher.
- Previous (surgical or endoscopic) anti-reflux procedure
- Previous surgery of the stomach or esophagus
- Sliding hiatal hernia >2cm
- Esophagitis grade C or D
- Presence of Barrett’s esophagus with dysplasia
- Known coagulopathy
- Unable to stop coagulants (with the exception of mono antiplatelet therapy)
- Presence of liver cirrhosis and/or esophageal varices
- Presence of a stricture of the esophagus
- Presence of eosinophilic esophagitis
- Presence of achalasia
- Presence of connective tissue disorder
- Absent peristalsis on high-resolution manometry
- Pregnancy at time of treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The total number of (acidic, weakly acidic and gas) gastroesophageal reflux episodes, as measured during 24-hour pH-impedance monitoring.
- Secondary Outcome Measures
Name Time Method