ACTRN12624001189516尚未招募Unknown
Assessing changes in oesophageal physiology and reflux in patients with gastro-oesophageal reflux disease (GORD) after a novel, minimally invasive endoscopic anti-reflux procedure – RAP (Resection and Plication).
Dr Calvin Park0 个研究点目标入组 10 人开始时间: 2024年9月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Change in Acid Exposure Time (AET) [pH/impedance study once baseline before RAP and once 3-6 months post-RAP. <br><br>There also may be further follow ups post-RAP as required, up to 24 months. <br><br>];Change patients' reported reflux symptoms [GERD-HRQL questionnaire once baseline pre-RAP and once 3-6 months post-RAP. <br>There also may be further follow ups post-RAP as required, up to 24 months. ]
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •The main inclusion criterion is that the patient has been deemed appropriate clinically and willing to undergo RAP procedure. The patient must be able to provide informed consent for the procedure and be of 18 years or older.Patients will have the following physiological and symptomatic characteristics on prior clinical assessments:•Patients with significant reflux as demonstrated by prolonged acid exposure time (AET) of 6% or more on a pH reflux study.•Patients with significant reflux symptoms (high symptom association probability, SAP) on a pH reflux study.•If patients demonstrated borderline AET of 4-6% - high reflux episodes (more than 80) or high SAP•Patients that are refractory to daily PPI therapy – AET 4% or more on a maximum tolerated acid lowering therapy.
排除标准
- •Patients who are not appropriate or eligible for RAP procedure•Prior anti-reflux procedures, including fundoplication and endoscopic plication or TIF•Prior gastric surgery, including weight reduction surgery•Presence of oesophageal motility disorder (Eg. Achalasia) as measured by manometry•Presence of a large hiatus hernia (greater than 2cm)•Significant mental health issue or cognitive impairment affecting ability to provide informed consent•Pregnant or breast feeding•Significant coagulopathy or those who cannot safely interrupt the course of anticoagulation for few days for the RAP procedure.
结局指标
主要结局
Change in Acid Exposure Time (AET) [pH/impedance study once baseline before RAP and once 3-6 months post-RAP. <br><br>There also may be further follow ups post-RAP as required, up to 24 months. <br><br>];Change patients' reported reflux symptoms [GERD-HRQL questionnaire once baseline pre-RAP and once 3-6 months post-RAP. <br>There also may be further follow ups post-RAP as required, up to 24 months. ]
次要结局
未报告次要终点
研究者
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