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Clinical Trials/ACTRN12623000501640
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.

Registry
who.int
Start Date
May 16, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Te Whatu Ora - Waitemata (North Shore Hospital)

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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