Gastroesophageal reflux heartburn reflux disease
Conditions
Interventions
After randomization, eighty patients will undergo endoluminal EsophyX*
fundoplication en will be compared to eighty patients who will undergo
laparoscopic Nissen fundoplication
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Perseverance of reflux related complaints for over 6 months despite of double dose PPI use ( >= 40 mg omeprazole / 24 hours or comparable therapy) and/or refusal of taking lifelong antireflux medication. - Patients without a diaphragmatic hernia or a sliding hernia of max. 2 cm (endoscopically measured distance from Z-line and impression of the diaphragm). - Pathological ambulatory 24 hour pH test (upright acid exposure > 8.4%, supine acid exposure > 3.4 % and/or total acid exposure > 5.8% and symptom association probability (SAP) > 95%) - Age: 18-65 years - Healthy patients with no disease outside of the surgical process 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: - Patients with a diaphragmatic hernia other than of the sliding type and / or larger than 2 cm (endoscopically measured). - Grade C and D esophagitis (Los Angeles classification). - Histologically proven long-segment Barrett*s esophagus (>2 cm). - Patients with severe objectified esophageal or gastric motility disorder. - Patients with a history of esophageal- or gastric surgery. - Patients with contraindications for undergoing a laparoscopic Nissen fundoplication or endoluminal fundoplication with Esophyx*, for example esophageal stenosis, esophageal stricture, portal hypertension, esophageal varices or diverticulae, active gastro-duodenal ulcer, previous Enteryx, Gatekeeper or Stretta treatment. - Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests. - Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with objective normalization of acid exposure, without suffering form severe dysphagia at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients free from PPI*s Quality of Life (QoL) and GERD related QoL (GERD-HRQoL) and esophageal symptoms (OES18-score) Percentage of patients with resolved, improved, unchanged and worsened symptoms (Visick grade) Prevalence of esophagitis Pressure of the Lower Esophageal Sphincter Percentage acidic, weakly acidic and gas reflux Total costs | — |
Countries
Netherlands
Outcome results
None listed