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Physiological Predictors of Clinical Outcomes After Anti-reflux Surgery

NCT03390634 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 343

Last updated 2019-08-22

No results posted yet for this study

Summary

Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach leaks up into the oesophagus (gullet) and causes symptoms such as heartburn and an unpleasant taste in the back of the mouth. GORD can often be controlled with self-help measures and medication. Occasionally, surgery to correct the problem may be needed.

A laparoscopic fundoplication is a keyhole (laparoscopic) procedure which is a highly effective treatment. Although reflux-related symptoms are absent or well controlled in over 85% of patients at 5 years after the operation, younger patients may have higher expectations that such an operation would hopefully last decades.

Oesophageal physiology tests such as 24-hour catheter pH (potential of hydrogen) and impedance involve passing a small tube into oesophagus via patients' nose to monitor the presence of stomach content (acid or non-acid) in the oesophagus. The manometry test measures the pressures and coordination of pressure activity within the oesophagus. Bravo™ wireless pH monitoring uses a capsule that is attached to the oesophageal lining. These tests are often used as part of a pre-operative evaluation before anti-reflux surgery (ARS).

Several measurements in these tests (also called parameters) could potentially anticipate clinical outcomes following anti-reflux surgery. The evidence for parameters like duration of acid exposure, number of reflux episodes and association with symptoms, pressures and co-ordination of pressure activity in the oesophagus, came from studies which were not designed in the most rigorous way to determine whether a cause-effect relation exists between treatment and outcome.

This is a single centre, retrospective, observational study in which patients who had pre-operative physiology testing and anti-reflux surgery at a tertiary centre in the last 10 years will be assessed for reflux symptoms and quality of life over the phone, based on three validated questionnaires. The study is designed to evaluate correlations between oesophageal physiology parameters and symptomatic response to ARS.

Conditions

  • Gastroesophageal Reflux

Interventions

OTHER

Gastroesophageal reflux symptoms questionnaires

Reflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL)

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
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 NCT03390634 on ClinicalTrials.gov