Physiological Predictors of Clinical Outcomes after Antireflux Surgery
Research type
Research Study
Full title
Oesophageal Manometry and Ambulatory Reflux Monitoring Predictors of Clinical Outcomes after Anti-reflux Surgery
IRAS ID
238959
Contact name
Terry Wong
Contact email
Sponsor organisation
Nottingham University Hospitals
Clinicaltrials.gov Identifier
NCT03390634, ClinicalTrials.gov ID
Duration of Study in the UK
1 years, 6 months, 1 days
Research 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 operation, younger patients may have higher expectations that such an operation would hopefully last decades.Oesophageal physiology tests such as 24-hour catheter pH and impedance involve passing a small tube into oesophagus via patients’ nose to monitor the presence of stomach content (acid or non-acid) in oesophagus. The manometry test measures the pressures and co-ordination of pressure activity within 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 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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0191
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion