MANTA-TRIAL; Randomized Controlled Trial of laparoscopic Toupet versus Anterior Fundoplication for Gastroesophageal Reflux Disease
- Conditions
- dysphagiareflux1001794310017998
- Registration Number
- NL-OMON39080
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 94
- Age >= 18 years
- Proven gastroesophageal reflux disease by either endoscopy or 24 hour pH monitoring.
- Clinically indicated anti-reflux surgery
- Fit for surgery
- Reflux disease inadequately controlled by medication of unwillingness to take lifelong medication
- Age < 18 years
- No informed consent
- Previous anti-reflux surgery
- Large hiatus hernia ( more than 50% of the stomach in the chest)
- Pregnant
- Esophageal aperistalsis
- Esophageal spasms or achalasia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective reflux control, dysphagia and gas related symptoms are the main study<br /><br>endpoints. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>
Related Research Topics
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