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

NCT03407456 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199

Last updated 2019-08-21

No results posted yet for this study

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

Interventions

OTHER

Gastroesophageal reflux symptoms questionnaire

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

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Terry Wong, MA MD · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-08-19
Completion
2019-08-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407456 on ClinicalTrials.gov