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
Protocol serial number	07-214
Sponsor	University Medical Center Utrecht and seven participating hospitals (The Netherlands)
Funders	The costs of this trial are internally covered by the eight participating hospitals in the Netherlands:, University Medical Center Utrecht, Meander Medical Center Amersfoort, Lange Land Hospital Zoetermeer, Catharina Hospital Eindhoven, Medical Center Leeuwarden, Antonius-Mesos Hospital Nieuwegein-Utrecht, Rivierenland Hospital Tiel, Amphia Hospital Breda

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

University Medical Center Utrecht
P.O. Box 85500
H.P. G04.228
Utrecht
3508 GA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised non-inferiority multicenter trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes