The SphynX trail: a randomised clinical trial comparing the outcome of endoluminal fundoplication with EsophyX™ to laparoscopic Nissen fundoplication for refractory gastro-esophageal reflux disease (GERD)
| ISRCTN | ISRCTN14127815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14127815 |
| Secondary identifying numbers | 07-214 |
- Submission date
- 17/02/2008
- Registration date
- 26/02/2008
- Last edited
- 26/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof H G Gooszen
Scientific
Scientific
University Medical Center Utrecht
P.O. Box 85500
H.P. G04.228
Utrecht
3508 GA
Netherlands
Study information
| Study design | Randomised non-inferiority multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SphynX |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | Gastro-esophageal reflux disease |
| Intervention | Endoluminal fundoplication with EsophyX™ versus laparoscopic Nissen fundoplication. |
| Intervention type | Other |
| 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 study start date | 01/01/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Center Utrecht and seven participating hospitals (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
H.P. G04.228
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl |
|---|---|
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Hospital/treatment centre
The costs of this trial are internally covered by the eight participating hospitals in the Netherlands:
No information available
University Medical Center Utrecht
No information available
Meander Medical Center Amersfoort
No information available
Lange Land Hospital Zoetermeer
No information available
Catharina Hospital Eindhoven
No information available
Medical Center Leeuwarden
No information available
Antonius-Mesos Hospital Nieuwegein-Utrecht
No information available
Rivierenland Hospital Tiel
No information available
Amphia Hospital Breda
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
