跳至主要内容
临床试验/ACTRN12623000501640
ACTRN12623000501640招募中Unknown

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 个研究点目标入组 50 人开始时间: 2023年5月16日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 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

排除标准

  • 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)

研究者

发起方
Te Whatu Ora - Waitemata (North Shore Hospital)

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