Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07-214
Study information
Scientific title
Acronym
SphynX
Study hypothesis
Endoluminal fundoplication with Esophyx™ will not be less effective than laparoscopic Nissen fundoplication, expressed as the percentage of successful procedures, based on the patient's opinion at six months after surgery.
Ethics approval
Independent central medical ethics committee of the University Medical Center Utrecht has approved the study protocol. Date of approval: 08/01/2008 (EC ref: 07-214; CCMO ref: 1795404107)
Study design
Randomised non-inferiority multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gastro-esophageal reflux disease
Intervention
Endoluminal fundoplication with EsophyX™ versus laparoscopic Nissen fundoplication.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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.
Recruitment start date
01/01/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Center Utrecht and seven participating hospitals (The Netherlands)
Sponsor details
P.O. Box 85500
H.P. G04.228
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The costs of this trial are internally covered by the eight participating hospitals in the Netherlands:
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University Medical Center Utrecht
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Meander Medical Center Amersfoort
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Lange Land Hospital Zoetermeer
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Catharina Hospital Eindhoven
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Medical Center Leeuwarden
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Antonius-Mesos Hospital Nieuwegein-Utrecht
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Rivierenland Hospital Tiel
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Amphia Hospital Breda
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Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list