MANTA/TRIAL, Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease
Completed
- Conditions
- gastroesophageal reflux disease, fundoplication, laparoscopic surgery
- Registration Number
- NL-OMON28375
- Lead Sponsor
- St Antonius Hospital, Nieuwegein
- Brief Summary
nvt
- 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.
Exclusion Criteria
- Age < 18 years
- No informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dysphagia score after 6 months
- Secondary Outcome Measures
Name Time Method - Objective reflux control<br /><br>- Gas-related symptoms<br /><br>- Subjective reflux control<br /><br>- Esophageal motility<br /><br>- Intraluminal pressure in the region of the fundoplication<br /><br>- Postoperative PPI use<br /><br>- Reintervention for dysphagia or recurrent reflux disease<br /><br>- Patient satisfaction<br /><br>- Major complications<br /><br>- duration of operation<br /><br>- in-hospital stay<br /><br>- minor complications, including superficial wound infection, urinary tract infection, bleeding without need for blood transfusion or re-intervention.