Gastroesophageal RefluxNCT02708303
Mayo Clinic Foregut Surgery Report Card Questionnaire
An observational study of Gastroesophageal Reflux and Fundoplication, run by Mayo Clinic at 1 site in United States.
Trial summary
The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Fundoplication, Hernia, Hiatal
- What is being tested?
- Mayo Clinic Foregut Surgery Report Card Questionnaire
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to 1 Oct 2018
- 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 undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.
- ≥ 18 years old
- Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.
Read the detailed description
Foregut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias. Patients undergoing foregut surgery report having varying degrees of symptoms of reflux, regurgitation, dysphagia, and pain following surgery. Providers also note varying degrees of outcomes. Some of these issues can be assessed using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, and other testing. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's outcomes but there is currently no assessment tool that brings all of the test findings and information reported by the patient as symptoms or answers to the questionnaires in a format that that is usable for the clinician and understandable for the patient who has specifically undergone foregut surgery. The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing surgery in the foregut in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Foregut Surgery Report Card Questionnaire. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of foregut procedure.
- Being tested
- Mayo Clinic Foregut Surgery Report Card Questionnaire
- Keywords
- Esophageal Reflux, Gastric Acid Reflux, Gastric Acid Reflux Disease, Gastro-Esophageal Reflux, Gastro-oesophageal Reflux, Gastroesophageal Reflux Disease, Reflux, Gastroesophageal, Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal, Hiatal Hernia, Sliding Hiatal Hernia, Sliding Esophageal Hernia, Hernia, Hiatus, Paraesophageal Hiatal Hernia, Questionnaires
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic Foregut Surgery Report Card QuestionnaireOther
Patients will be asked to complete the Mayo Clinic Foregut Surgery Report Card Questionnaire at approximately 8-10 weeks following surgery and then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.
Data collected from the questionnaire will be entered into a database that will be maintained for future research.
| Study group | Role | What they receive |
|---|---|---|
| Foregut Surgery | Foregut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias. Receives: Other: Mayo Clinic Foregut Surgery Report Card Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery
Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be analyzed and used to establish validation.
Measured: 1 year
Secondary outcomes (1)
Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires
Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be used in the establishment of "normal" or expected scores for patients undergoing each type of foregut surgery at different time points following surgery.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start17 Mar 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Why it stopped: Study's original Principal Investigator no longer at the institution.
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 Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janani S. Reisenauer, Mayo Clinic
- Investigators
- Janani Reisenauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708303
- Sponsor's protocol ID
- 16-001151
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2016
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Foregut Surgery Report Card Questionnaire
- ClinicalTrials.gov ID
- NCT02708303
- Acronym / sponsor ID
- 16-001151
- Keywords
- Esophageal Reflux, Gastric Acid Reflux, Gastric Acid Reflux Disease, Gastro-Esophageal Reflux, Gastro-oesophageal Reflux, Gastroesophageal Reflux Disease, Reflux, Gastroesophageal, Esophageal Hernia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study's original Principal Investigator no longer at the institution.
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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.
The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.
Detailed description
Foregut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias. Patients undergoing foregut surgery report having varying degrees of symptoms of reflux, regurgitation, dysphagia, and pain following surgery. Providers also note varying degrees of outcomes. Some of these issues can be assessed using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, and other testing. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's outcomes but there is currently no assessment tool that brings all of the test findings and information reported by the patient as symptoms or answers to the questionnaires in a format that that is usable for the clinician and understandable for the patient who has specifically undergone foregut surgery. The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing surgery in the foregut in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Foregut Surgery Report Card Questionnaire. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of foregut procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foregut Surgery | – | Other: Mayo Clinic Foregut Surgery Report Card QuestionnaireForegut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.
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 |
|---|---|---|
| Mayo Clinic Foregut Surgery Report Card QuestionnairePatients will be asked to complete the Mayo Clinic Foregut Surgery Report Card Questionnaire at approximately 8-10 weeks following surgery and then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information. Data collected from the questionnaire will be entered into a database that will be maintained for future research. | Other | Foregut Surgery |
Primary outcome
Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery
Time frame: 1 year
Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be analyzed and used to establish validation.
1 secondary outcome
Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Study's original Principal Investigator no longer at the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Janani Reisenauer, MD principal investigator
Mayo Clinic
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 and Fundoplication, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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 States. 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 was stopped early (reason given: Study's original Principal Investigator no longer at the institution.). Results are not available in the source record.
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?
Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery (time frame: 1 year). 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 Mar 2024.