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MANTA-TRIAL; Randomized Controlled Trial of laparoscopic Toupet versus Anterior Fundoplication for Gastroesophageal Reflux Disease

Completed
Conditions
dysphagia
reflux
10017943
10017998
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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
<p>Objective reflux control, dysphagia and gas related symptoms are the main study<br /><br>endpoints. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>not applicable</p><br>
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