Endoscopic versus Surgical Treatment of Reflux

Not Applicable

Recruiting

• Conditions: Reflux; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12623000501640
• Lead Sponsor: Te Whatu Ora - Waitemata (North Shore Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Symptomatic gastro-oesophageal reflux, despite 2 months twice daily of PPI (proton pump inhibitor) use, and attempts to optimise lifestyle measures contributing to reflux events.
Confirmation of pathological reflux via 24-hr Oesophageal pH testing; either
•Acid Exposure Time >6%
•DeMeester Score >14.7
•Positive SAP (symptom association probability) (95%) with SI (Symptom index) >70%
Or:
•Los Angeles (LA) Grade C-D oesophagitis

High resolution oesophageal manometry performed in all patients to confirm the absence of major oesophageal motility disorders.

Consenting to participate in trial: willing to undergo either ARMA or surgical fundoplication

Exclusion Criteria

Hiatus Hernia; Hill Grade IV or sliding hiatus hernia >2cm
Contra-indications to surgical fundoplication
-Previous major abdominal surgery precluding laparoscopy
-Previous gastric surgery
Major motility disorder on HR (high resolution) manometry assessment (as defined by Kahrilas et al)
-Minor motility disorder with functional impact (abnormal Ba swallow or solid food challenge)
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified