Gastroesophageal RefluxNCT03390634
Physiological Predictors of Clinical Outcomes After Anti-reflux Surgery
An observational study of Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Gastroesophageal reflux symptoms questionnaires
- How many people
- 343 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2018to 19 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastro-oesophageal reflux confirmed on physiology testing and treated with anti-reflux surgery at a single tertiary centre over 10 years.
Who may be able to join
- Males and non-pregnant females over the age of 18 years.
- Gastro-oesophageal symptoms in accordance with Montreal criteria49
- Patients who had oesophageal physiology testing at Guy's and St Thomas' NHS Foundation Trust
- Oesophageal manometry based on Chicago classification
- 24-hour standard pH, impedance-pH and Bravo™
- Minimum 6 months post ARS and follow-up at GSTT
- Verbal consent over the phone
Who cannot join
- Patients less than 18 years of age.
- Pregnancy at the time of interview
- Patients unable to comprehend or answer the questionnaires
- Oesophageal physiology tests performed in other centres
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Oesophageal Manometry and Ambulatory Reflux Monitoring Predictors of Clinical Outcomes After Anti-reflux Surgery
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.
Read more
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.
Read the detailed description
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:
- Patients will be assessed based on the Reflux Disease Questionnaire (RDQ) which is designed to assess the frequency and severity of heartburn, regurgitation and dyspeptic symptoms. Response options are scaled as Likert-type with scores for and severity. RDQ demonstrated validity and reliability in multiple languages and represents a viable instrument for assessing symptom severity and response to treatment.
- Patients will also be assessed based on The Reflux Symptoms Index (RSI) questionnaire which evaluates the presence and severity of laryngopharyngeal reflux (LPR). RSI can be completed in less than one minute. It is easily administered, highly reproducible and demonstrated design- and criteria-based validity in multiple languages.
- Participants will finally be evaluated based on the Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) questionnaire which is aimed at typical reflux symptoms and impact on the daily living. The questionnaire can be easily given over the phone in less than 2 minutes. GORD-HRQL has been validated and is a reliable and practical tool in several languages.
- Data recorded will include the standard components of pre-operative oesophageal pH monitoring and high-resolution manometry, reflux symptoms scores, PPIs (proton pump inhibitors) usage, post-operative physiology studies and re-do anti-reflux surgery.
- Statistical analysis will involve multiple logistic regression and multiple linear regression models. Sensitivity and specificity of each predictor will be measured using the Receiver Operating Characteristic (ROC) curve analysis. A minimum of 350 patients for 5 predictors will define our sample size.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Gastroesophageal reflux symptoms questionnaires
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastroesophageal reflux symptoms questionnairesOther
Reflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL)
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux Disease Questionnaire (RDQ) score improvement ratio after anti-reflux surgery
≥ 50% improvement in RDQ scores is considered a successful outcome
Measured: 1 day
Reflux Symptoms Index (RSI) threshold score after anti-reflux surgery
RSI score after anti-reflux surgery
Measured: 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
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
Number of patients requiring re-do anti-reflux surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start5 Mar 2018
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Wong, MA MD, Principal investigator, Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390634
- Sponsor's protocol ID
- 238959
- Status last verified
- Aug 2019
- First submitted
- 29 Dec 2017
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oesophageal Manometry and Ambulatory Reflux Monitoring Predictors of Clinical Outcomes After Anti-reflux Surgery
- ClinicalTrials.gov ID
- NCT03390634
- Acronym / sponsor ID
- 238959
- Conditions
- Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Patients will be assessed based on the Reflux Disease Questionnaire (RDQ) which is designed to assess the frequency and severity of heartburn, regurgitation and dyspeptic symptoms. Response options are scaled as Likert-type with scores for and severity. RDQ demonstrated validity and reliability in multiple languages and represents a viable instrument for assessing symptom severity and response to treatment.
- Patients will also be assessed based on The Reflux Symptoms Index (RSI) questionnaire which evaluates the presence and severity of laryngopharyngeal reflux (LPR). RSI can be completed in less than one minute. It is easily administered, highly reproducible and demonstrated design- and criteria-based validity in multiple languages.
- Participants will finally be evaluated based on the Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) questionnaire which is aimed at typical reflux symptoms and impact on the daily living. The questionnaire can be easily given over the phone in less than 2 minutes. GORD-HRQL has been validated and is a reliable and practical tool in several languages.
- Data recorded will include the standard components of pre-operative oesophageal pH monitoring and high-resolution manometry, reflux symptoms scores, PPIs (proton pump inhibitors) usage, post-operative physiology studies and re-do anti-reflux surgery.
- Statistical analysis will involve multiple logistic regression and multiple linear regression models. Sensitivity and specificity of each predictor will be measured using the Receiver Operating Characteristic (ROC) curve analysis. A minimum of 350 patients for 5 predictors will define our sample size.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastro-oesophageal reflux confirmed on physiology testing and treated with anti-reflux surgery at a single tertiary centre over 10 years.
Key inclusion criteria (7 listed)
- Males and non-pregnant females over the age of 18 years.
- Gastro-oesophageal symptoms in accordance with Montreal criteria49
- Patients who had oesophageal physiology testing at Guy's and St Thomas' NHS Foundation Trust
- Oesophageal manometry based on Chicago classification
- 24-hour standard pH, impedance-pH and Bravo™
Key exclusion criteria (4 listed)
- Patients less than 18 years of age.
- Pregnancy at the time of interview
- Patients unable to comprehend or answer the questionnaires
- Oesophageal physiology tests performed in other centres
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastroesophageal reflux symptoms questionnairesReflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) | Other | – |
Primary outcome
Reflux Disease Questionnaire (RDQ) score improvement ratio after anti-reflux surgery
Time frame: 1 day
≥ 50% improvement in RDQ scores is considered a successful outcome
Reflux Symptoms Index (RSI) threshold score after anti-reflux surgery
Time frame: 1 day
RSI score after anti-reflux surgery
Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) threshold scores after anti-reflux surgery
Time frame: 1 day
GORD-HRQL score after anti-reflux surgery
2 secondary outcomes
Dosage of proton pump inhibitors (PPI) per day after anti-reflux surgery
Time frame: 1 day
Number of patients requiring re-do anti-reflux surgery
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Wong, MA MD principal investigator
Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux Disease Questionnaire (RDQ) score improvement ratio after anti-reflux surgery (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.