Gastroesophageal RefluxNCT03661151
Comparison of Treatment Outcome and Cost-effectiveness for GERD
An observational study of Gastroesophageal Reflux, run by Sungsoo Park at 1 site in South Korea.
Trial summary
This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2018to 31 Dec 2020
- How long will I take part?
- 3 Months
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery
Who may be able to join
- Objectively diagnosed GERD
- Past history of medical treatment with PPI more than 8 weeks at any time before antireflux surgery
- Patients scheduled to undergo antireflux surgery to treat GERD
Who cannot join
- Other pathologic condition in upper gastrointestinal tract which needs surgical treatment
- No (or less than 8 weeks) past history of acid suppressive medical therapy with PPI
- Patients who underwent endoscopic antireflux procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Sungsoo Park
About this study
Official title: Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment.
Read the detailed description
To treat GERD, the most patients with GERD are managed with acid suppressive medication first, and followed by antireflux surgery when the medical therapy is not effective or when the patient prefer surgery to quit the medicine.
This study has a single cohort in which the patient has the past history of GERD and medical treatment with proton pump inhibitors, and has scheduled to have laparoscopic antireflux surgery for treatment of GERD.
Treatment outcome of surgery will be evaluated comparing with the outcome of medical treatment before registration.
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal reflux disease, Antireflux surgery
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antireflux surgery following PPI | A single cohort with the GERD patients who had acid suppressive medication with proton pump inhibitor (PPI) followed by laparoscopic antireflux surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
GERD symptom control rate of surgical and non-surgical treatment for GERD based on the GERD symptom questionaire
Measured: Change from baseline GERD symptom at 3 months after antireflux surgery
Secondary outcomes (2)
Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
Evaluation of medical cost based on public insurance system and patients' history
Measured: Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery
Complication rate and adverse symptom rate related with antireflux surgery
Surgical complication and adverse symptom related with antireflux surgery evaluated with GERD symptom questionaire and case records
Measured: Change from baseline GERD symptom at 3 months after antireflux surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start25 Feb 2018
- Primary completion25 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sungsoo Park
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Hospital, Kosin University Gospel Hospital
- Responsible party
- Sponsor-investigator, Sungsoo Park, Korea University Anam Hospital
- Investigators
- Sungsoo Park, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661151
- Sponsor's protocol ID
- GERD-PPI-ARS
- Status last verified
- Mar 2020
- First submitted
- 15 Jun 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT03661151
- Acronym / sponsor ID
- GERD-PPI-ARS
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal reflux disease, Antireflux surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sungsoo ParkUniversity, hospital or other
- Collaborators
- Chung-Ang University Hospital, Kosin University Gospel Hospital
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 25 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Sep 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.
This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment.
Detailed description
To treat GERD, the most patients with GERD are managed with acid suppressive medication first, and followed by antireflux surgery when the medical therapy is not effective or when the patient prefer surgery to quit the medicine.
This study has a single cohort in which the patient has the past history of GERD and medical treatment with proton pump inhibitors, and has scheduled to have laparoscopic antireflux surgery for treatment of GERD.
Treatment outcome of surgery will be evaluated comparing with the outcome of medical treatment before registration.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antireflux surgery following PPI | – | –A single cohort with the GERD patients who had acid suppressive medication with proton pump inhibitor (PPI) followed by laparoscopic antireflux surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery
Key inclusion criteria (3 listed)
- Objectively diagnosed GERD
- Past history of medical treatment with PPI more than 8 weeks at any time before antireflux surgery
- Patients scheduled to undergo antireflux surgery to treat GERD
Key exclusion criteria (3 listed)
- Other pathologic condition in upper gastrointestinal tract which needs surgical treatment
- No (or less than 8 weeks) past history of acid suppressive medical therapy with PPI
- Patients who underwent endoscopic antireflux procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
Time frame: Change from baseline GERD symptom at 3 months after antireflux surgery
GERD symptom control rate of surgical and non-surgical treatment for GERD based on the GERD symptom questionaire
2 secondary outcomes
Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
Time frame: Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery
Complication rate and adverse symptom rate related with antireflux surgery
Time frame: Change from baseline GERD symptom at 3 months after antireflux surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Sungsoo Park, MD, PhD principal investigator
Korea University Anam Hospital
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 Sungsoo Park at 1 site in South Korea.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sungsoo Park, MD, PhD (+82-2-920-6772, kugspss@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD) (time frame: Change from baseline GERD symptom at 3 months after antireflux surgery). 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 18 Mar 2020.