Gastro-esophageal reflux disease Digestive System Gastro-esophageal reflux disease
Conditions
Interventions
Endoluminal fundoplication with EsophyX™ versus laparoscopic Nissen fundoplication.
Sponsors
University Medical Center Utrecht and seven participating hospitals (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. GERD patients of eight Dutch hospitals with reflux symptoms persisting for over 6 months despite double dose of Proton Pump Inhibitor (PPI) (>40 mg omeprazole/24 hours or comparable therapy) and/or patients who refuse or do not tolerate to take acid suppressing drugs for life. 2. Documented temporal relation between pathological reflux and symptoms during 24-hr pH monitoring. Pathological reflux is defined as upright acid exposure >8.4%, supine acid exposure >3.4 % and/or total acid exposure >5.8% on 24-hr pH monitoring. A documented relation between reflux and symptoms is reflected by a Symptom Association Probability (SAP) >95%. 3. Patients without a diaphragmatic hernia or a sliding hernia not exceeding 2 cm (endoscopically measured distance from Z-line and impression of the diaphragm). 4. Age between 18 and 65 years. 5. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a diaphragmatic hernia other than of the sliding type and/or larger than 2 cm. 2. Grade C and D esophagitis according to the Los Angeles classification. 3. Histologically proven long-segment Barrett's oesophagus. 4. Patients with severe esophageal or gastric motility disorders. 5. Patients with a history of esophageal- or gastric surgery. 6. American Society of Anaesthesiologists classification III and IV patients. 7. Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective esophageal function tests. 8. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness will be expressed as the percentage of successful procedures, based on the patient's opinion at six months after surgery (Visick grading). Visick classification: grade I: No symptoms, resolved; grade II: Mild occasional symptoms easily controlled, improved; grade III: Mild symptoms not controlled, unchanged; grade IV: Not improved, worsened. Success will be defined as grade I or II and failure will be defined as grade III or IV. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Success expressed as the percentage of patients with normalisation of acid exposure on pH metry, minus the percentage of patients needing reintervention (dilatation or re-operation) for troublesome dysphagia at six months Definition of objective normalisation of acid exposure: The combination of the following: a. Upright acid exposure <8.4% b. Supine acid exposure <3.4 % c. Total acid exposure <5.8% on post-operative 24-h pH-monitoring The presence of troublesome dysphagia will render the procedure unsuccessful. 2. Percentage of patients free from PPIs at three and six months 3. Quality of Life (QoL) assessment: Visual analogue scale [VAS] score, the 36-item Short Form health survey (SF-36) and EuroQol (EQ-5D) at three and six months 4. Impact of reflux symptoms on QoL: The Gastro-Oesophageal Reflux Disease Health-Related Quality-of-Life scale (GORD-HRQoL) at three and six months 5. Esophageal symptoms: OES18 score at three and six months 6. Prevalence of esophagitis on upper endoscopy at six months 7. Cost-effectiveness expressed as costs per successfully treated patients and incremental costs per Quality Adjusted Life Year gained at six months | — |
Countries
Netherlands
Outcome results
None listed