ACTRN12623000501640
Recruiting
未知
Quality of Life Following Endoscopic Anti-Reflux Mucosal Ablation versus Nissen Fundoplication for Refractory Reflux: a blinded randomised control trial
Te Whatu Ora - Waitemata (North Shore Hospital)0 sites50 target enrollmentMay 16, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Te Whatu Ora - Waitemata (North Shore Hospital)
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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%
- •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)
Outcomes
Primary Outcomes
Not specified
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