Comparison of Treatment Outcome and Cost-effectiveness for GERD
Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2018
CompletedFirst Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 18, 2020
March 1, 2020
2.7 years
June 15, 2018
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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)
Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery
Complication rate and adverse symptom rate related with antireflux surgery
Change from baseline GERD symptom at 3 months after antireflux surgery
Study Arms (1)
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
Eligibility Criteria
GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, 02841, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sungsoo Park, MD, PhD
Korea University Anam Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2018
First Posted
September 7, 2018
Study Start
February 25, 2018
Primary Completion
October 25, 2020
Study Completion
December 31, 2020
Last Updated
March 18, 2020
Record last verified: 2020-03