Gastroesophageal Reflux DiseaseNCT00260572
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Questionnaires to evaluate QOL, Questionnaires to evaluate heartburn and quality of life and Questionnaire to evaluate satisfaction with treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 a diagnosis of reflux seeking treatment in a physician's office.
Who may be able to join
- Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:
- heartburn
- acid regurgitation
- waterbrash
- non-cardiac chest pain
- dyspepsia
Show all 9Show fewer
- Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
- Patients scheduled for surgical management of GERD and/or hiatal hernia
- Patients currently or commencing treatment with at least proton pump inhibitors or pro-motility agents.
Who cannot join
- Patients unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15213
About this study
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.
Read the detailed description
GERD is a significant public health problem and when it is severe it may have a considerable impact on patients' QOL. Relatively new treatments such as proton pump inhibitors (PPI) and laparoscopic fundoplication (wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux) are now available. Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments. Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD.
This study's goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD. In addition we want to measure standard outcomes such as morbidity, mortality, medication use and patient derived outcomes such as general and disease specific QOL, and patient satisfaction with the treatment. We also want to assess if and how long QOL is improved by medical and surgical treatment methods. In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical (an operation) rather than the medical treatment. It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD. Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Questionnaires to evaluate QOL, Questionnaires to evaluate heartburn and quality of life, Questionnaire to evaluate satisfaction with treatment, Questionnaire to evaluate presence or absence of pain
- Keywords
- GERD, nissen, fundoplication, reflux, toupet, QOL, dyspepsia, heartburn, Patients with reflux symptoms for at least 6 months, Patients scheduled for lap nissen or toupet fundoplication, Reflux diagnosed by either endoscopy, upper GI, or 24hr. pH (numeric scale used to specify the acidity of gastric contents), On or starting treatment with PPI or pro-motility agents
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires to evaluate QOLBehavioural
Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
Questionnaires to evaluate heartburn and quality of lifeBehavioural
Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
Questionnaire to evaluate satisfaction with treatmentBehavioural
Questionnaire administered postoperatively at set intervals.
Questionnaire to evaluate presence or absence of painBehavioural
Questionnaire administered preoperatively and at set intervals postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startApr 1999
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Luketich, University of Pittsburgh
- Investigators
- James D. Luketich, MD, Principal investigator, Department of Cardiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260572
- Sponsor's protocol ID
- STUDY20050057
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2005
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00260572
- Acronym / sponsor ID
- STUDY20050057
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, nissen, fundoplication, reflux, toupet, QOL, dyspepsia, heartburn
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 1999
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 1 Dec 2005 (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 aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.
Detailed description
GERD is a significant public health problem and when it is severe it may have a considerable impact on patients' QOL. Relatively new treatments such as proton pump inhibitors (PPI) and laparoscopic fundoplication (wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux) are now available. Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments. Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD.
This study's goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD. In addition we want to measure standard outcomes such as morbidity, mortality, medication use and patient derived outcomes such as general and disease specific QOL, and patient satisfaction with the treatment. We also want to assess if and how long QOL is improved by medical and surgical treatment methods. In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical (an operation) rather than the medical treatment. It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD. Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of reflux seeking treatment in a physician's office.
Key inclusion criteria (9 listed)
- Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:
- Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
- Patients scheduled for surgical management of GERD and/or hiatal hernia
- Patients currently or commencing treatment with at least proton pump inhibitors or pro-motility agents.
Key exclusion criteria (2 listed)
- Patients unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
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 |
|---|---|---|
| Questionnaires to evaluate QOLQuestionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals. | Behavioural | – |
| Questionnaires to evaluate heartburn and quality of lifeQuestionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively. | Behavioural | – |
| Questionnaire to evaluate satisfaction with treatmentQuestionnaire administered postoperatively at set intervals. | Behavioural | – |
| Questionnaire to evaluate presence or absence of painQuestionnaire administered preoperatively and at set intervals postoperatively. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
James D. Luketich, MD principal investigator
Department of Cardiothoracic Surgery
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 Disease, run by University of Pittsburgh 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?
The sponsor lists 9 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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.
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 14 Apr 2026.