Endoluminal fundoplication with the Esophyx*-device versus proton-pump-inhibition in treatment of Gastro-esophageal reflux disease (GERD).

Endoluminal fundoplication with the Esophyx*-device versus proton-pump-inhibition in treatment of Gastro-esophageal reflux disease (GERD). - Endoluminal fundoplication (Esophyx-device)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31490

Enrollment

Registered

2008-01-30

Start date

2008-06-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-esophageal relux disease

Interventions

Discontinuation of all anticoagulants and platelet agents (including aspirin) > 10 days before the elf procedure will be organized if applicable. The patient should be instructed not to eat of drink

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. Hiatal hernia 1 year 7. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Immobile or non-reducible hiatal hernia 2. Hiatal hernia >2 cm 3. Esophagitis grade D 4. Barret's Esophagus 5. Esophageal stricture 6. Esophageal ulcer 7. Esophageal motility disorder 8. Gastric motility disorder 9. Prior sleenectomy 10. Gastric paralysis 11. Pregnancy 12. Immunosuppression 13. ASA >2 14. Abnormal manometry-measurements 15. History of stomach-surgery 16. BMI >35 17. Portal hypertension 18. Coagulation disorders 19. Mental retardation 20. Lack of fluency in English

Design outcomes

Secondary

Measure	Time frame
Use of anti-GORZ-medication Cost-effectiveness-analysis Complications and adverse effects Esophagusbiopsy and blood samples will be compared 24-h-pH-metry/impedance-measurements	—

Primary

Measure	Time frame
Quality of life-scores (GERD-HRQL, EuroQol and GSRS)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)