Gastroesophageal reflux reflux disease
Conditions
Interventions
After randomization, twenty-five patients will undergo laparoscopic Toupet
fundoplication and will be compared to twenty-five patients who will undergo
laparoscopic Nissen fundoplication.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Persisting reflux related complaints for over 6 months despite double dose PPI use ( * 40 mg omeprazole / 24 hours or comparable therapy) and/or refusal of taking lifelong antireflux medication. - Pathological ambulatory 24 hour pH test (total acid exposure > 5.8% and/or symptom association probability (SAP) > 95%) - Adults - Healthy patients with no disease other than the disorder for which the operations carried out and patients with mild to moderate systemic disease caused by the surgical condition or by other pathological processes, medically well-controlled (American Society of Anaesthesiologists classification of preoperative risk 1 or 2)
Exclusion criteria
Exclusion criteria: - History of gastric or esophageal surgery - Esophageal aperistalsis - Achalasia - Esophageal spasms - Contraindications against undergoing laparoscopic antireflux surgery - Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the esophageal function tests.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Dysphagia (Mayo Dysphagia Questionaire) 2. Esophageal transit time - Esophageal transit time and esophageal diameter on timed barium esophagram - Esophagogastric transit time on impedance monitoring 3. Esophageal motility on high-resolution manometry 4. Compliance of the EGJ, quantified as the cross-sectional area of EGJ after volume controlled distension, using a Functional Lumen Imaging Probe (FLIP) 5. Severe dysphagia, defined as: dysphagia needing reintervention (balloon dilatation or surgical reintervention), causing weight loss or requiring diet changes. 6. Reflux symptoms (RDQ) 7. Quality of Life (SF-36) | — |
Primary
| Measure | Time frame |
|---|---|
| Residual relaxation pressure of the EGJ on high-resolution manometry. | — |
Countries
Netherlands
Outcome results
None listed