Reflux disease
Conditions
Interventions
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of (acidic, weakly acidic and gas) gastroesophageal reflux episodes, as measured during 24-hour pH-impedance monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of anti-reflux mucosectomy on: - Total, upright and supine acid exposure time during 24-hour pH-impedance studies. - The prevalence of transient lower esophageal sphincter relaxations (TLESRs) during a 90-minute postprandial stationary measurement. - The number of acidic, weakly acidic and gas gastroesophageal reflux episodes during the 90-min postprandial stationary period. - Manometric features of the esophagogastric junction (integrated relaxation pressure (IRP), lower esophageal sphincter resting pressure, presence of hiatal hernia) and esophageal body, as assessed with stationary high-resolution manometry. - Esophagogastric junction distensibility measured with endoFLIP. - Grade of the gastroesophageal flap valve, using the Hill classification. - Grade of esophageal erosive esophagitis, using the Los Angeles classification. - Reflux symptom score assessed by the Reflux Disease Questionnaire (RDQ). - Quality of life scores assessed by the health-related quality of life for GERD (GERD-HRQL) - PPI use To describe procedure-related adverse events - Occurrence of post-procedure strictures assessed by endoscopy at 3-months follow-up. - Presence of dysphagia as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ) - Other complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. | — |
Contacts
Public ContactRenske Oude Nijhuis
Amsterdam UMC
Outcome results
None listed