Multicentre Randomised Controlled Trial of Anterior vs Posterior vs Nissen Fundoplication
Anterior versus Posterior versus Nissen Fundoplication for the control of gastro-oesophageal reflux
ISDE - Australasian section
100 participants
Dec 31, 2012
Interventional
Conditions
Summary
Multicentre prospective double blind randomized controlled trial comparing 3 surgical procedures for gastro-oesophageal reflux. All groups will undergo a clinically acceptable operation, according to standard clinical indications. The study will be performed in multiple centres throughout Australia and New Zealand. The study will be coordinated from FMC and RAH in SA. Patients will be recruited over a 2 year period. Follow-up will continue for up to 20 years.
Eligibility
Inclusion Criteria1
- Proven gastro-oesophageal reflux disease by either endoscopic or 24 hour pH monitoring. Antireflux surgery clinically indicated. Fit for surgery. Reflux inadequately controlled by standard medications or unwilling to take lifelong medication for reflux.
Exclusion Criteria1
- No informed consent. Previous surgery for gastro-oesophageal reflux. Very large hiatus hernia (more than 50% of stomach in the chest). PregnantOesophageal motility disorder which precludes Nissen fundoplication.
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Interventions
Laparoscopic fundoplication - Anterior vs Posterior vs Nissen Fundoplication
Locations(1)
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ACTRN12605000035628