Assessing the efficacy of Resection and Plication (RAP) on oesophageal physiology and symptoms in patients with gastro-oesophageal reflux disease (GORD).

Not Applicable

Not yet recruiting

• Conditions: gastro-oesophageal reflux disease (GORD); Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624001189516
• Lead Sponsor: Dr Calvin Park

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-30
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. ]