Multicentre Randomised Controlled Trial of Anterior vs Posterior vs Nissen Fundoplication

Anterior versus Posterior versus Nissen Fundoplication for the control of gastro-oesophageal reflux

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000035628

Enrollment

100

Registered

2005-07-22

Start date

2012-12-31

Completion date

2012-12-31

Last updated

2025-09-08

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

Conditions

None listed

Brief 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.

Interventions

Laparoscopic fundoplication - Anterior vs Posterior vs Nissen Fundoplication

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results