Condition category
Digestive System
Date applied
17/02/2008
Date assigned
26/02/2008
Last edited
26/02/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.esophyx.nl

Contact information

Type

Scientific

Primary contact

Prof H G Gooszen

ORCID ID

Contact details

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

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 measures

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

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

http://www.umcutrecht.nl

Funders

Funder type

Hospital/treatment centre

Funder name

The costs of this trial are internally covered by the eight participating hospitals in the Netherlands:

Alternative name(s)

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Location

Funder name

University Medical Center Utrecht

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Funder name

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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Funder name

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes