Correlations Between Wireless pH Monitoring and Variation in Reflux Symptom Questionnaire, 7 Day Recall

NCT03407456 | Completed

• 1 other identifier: 236758
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

The diagnosis of gastro-oesophageal reflux disease (GORD) is often based on 24-hour catheter-based pH studies. The Bravo™ wireless pH monitoring revolutionised the study of GORD, allowing patients an improved comfort and ability to perform activities of daily living. The backflow of gastric acid (acid exposure) in the oesophagus is monitored by a tiny pH sensor located in a capsule which is pinned temporarily to the wall of the oesophagus at the time of endoscopy. Normal measurements (also called parameters) for acid exposure are established for 48-hour studies. However, our studies have shown that extending the duration of recording to 96 hours further improved the diagnostic yield for GORD in patients with negative 24-hour catheter-based tests. While pathologic acid exposure and symptom-reflux association in catheter-based pH studies anticipate a successful outcome after anti-reflux surgery, the clinical relevance of increasing the duration of recording is lacking. This study aims to investigate the relationship between the result of participants Bravo test and their symptoms on their usual medication. This is a single centre, prospective, observational study enrolling males and non-pregnant females over the age of 18 years with gastro-oesophageal symptoms in accordance with Montreal criteria and who have clinical indications for Bravo™. The study is based on questionnaires. All clinical interventions, including 96-hour Bravo™ pH monitoring, temporary cessation of medication and outpatient clinic follow-up is offered as routine medical care, regardless of their participation in the study. Patients will be contacted over the phone ten days before the procedure by a member of the research team involved in their clinical care and asked whether they would be interested in joining the study. Participants will complete a "baseline" 7-day recall Reflux Symptom Questionnaire (RESQ-7) before having Bravo™ for 96 hours. Participants will have a telephone follow-up at 4 weeks and 8 weeks to assess their symptoms based on the RESQ-7 questionnaire. We anticipate the recruitment of 100 subjects over 14 months. The final endpoints will be achieved 6 months after the last patient has been interviewed.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Reflux Symptom Questionnaire-7-day recall (RESQ-7) scores at 4 weeks on treatment with PPIs

  A ≥ 50% improvement in RESQ-7 scores from baseline is considered a successful outcome. RESQ-7 contains 13 items which are aggregated to 4 frequency and 4 intensity domain scores: heartburn (5 items), regurgitation (4 items), cough, hoarseness, difficulty swallowing (3 items), burping (1 item). Each item is rated on a 6-point scale ranging from 0 to 5: 0=did not have; 1=very mild/1 day; 2=mild/2 days; 3=moderate/3-4 days; 4=moderately severe/5-6 days; 5=severe/daily.

  4 weeks

Secondary Outcomes (2)

• Comparison of RESQ-7 scores at 4 weeks and 8 weeks

  8 weeks

• Overall change in RESQ-7 scores from baseline.

  8 weeks

Interventions

Gastroesophageal reflux symptoms questionnaire OTHER

Reflux Symptom Questionnaire, 7-day recall (RESQ-7).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for wireless 96-hour pH monitoring as part of their usual clinical care

You may qualify if:

• Males and non-pregnant females over the age of 18 years.
• Gastro-oesophageal symptoms in accordance with Montreal criteria#
• Patients with clinical indications for Bravo™, including:
• symptomatic patients with non-diagnostic endoscopy and catheter-based pH tests
• preoperative evaluation before antireflux procedures
• persistent or recurrent post-operative symptoms
• Participants need to understand spoken and written English
• Patients must sign an informed consent form.

You may not qualify if:

• Contraindications to endoscopy
• Known allergy or intolerance to PPI
• History of bleeding diathesis or coagulopathy
• Chronic liver disease, oesophageal varices
• Pregnancy
• Any medical or non-medical condition that in the opinion of the research team will make the candidate unfit for this study, such as heart failure and drug abuse.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Terry Wong, MA MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: March 20, 2018
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)