Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. Bravoâ„¢ 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.
This is a single centre, retrospective, cross-sectional study on patients who had anti-reflux surgery and pre-operative oesophageal physiology testing over 10 years. The investigators anticipate the recruitment of up to 350 subjects over 18 months.
Eligible patients will be contacted over the phone and asked whether they would be interested in joining the study. Candidates will be presented with details no less than the exact nature of the study, the implications and constraints of the protocol. Subjects will be made aware that no intervention will be made in this study, therefore taking part involves no risks or side effects. If all questions that satisfy inclusion and exclusion criteria are answered satisfactorily, and patients are happy to enter the study, participants will be consented verbally over the phone. It will be stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
Once recruited the following assessments and interventions will take place:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastroesophageal reflux symptoms questionnaires | Other | Reflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) |
| Measure | Description | Time Frame |
|---|---|---|
| Reflux Disease Questionnaire (RDQ) score improvement ratio after anti-reflux surgery | ≥ 50% improvement in RDQ scores is considered a successful outcome | 1 day |
| Reflux Symptoms Index (RSI) threshold score after anti-reflux surgery | RSI score after anti-reflux surgery | 1 day |
| Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) threshold scores after anti-reflux surgery | GORD-HRQL score after anti-reflux surgery | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of proton pump inhibitors (PPI) per day after anti-reflux surgery | Compare dosage of proton pump inhibitors (PPI) per day pre- and post anti-reflux surgery | 1 day |
| Number of patients requiring re-do anti-reflux surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with gastro-oesophageal reflux confirmed on physiology testing and treated with anti-reflux surgery at a single tertiary centre over 10 years.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Terry Wong, MA MD | Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 day |
| D004066 | Digestive System Diseases |