Comparison of Treatment Outcome and Cost-effectiveness for GERD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)

Conditions
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Gastroesophageal Reflux

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antireflux surgery following PPI<br>A single cohort with the GERD patients who had acid suppressive medication with proton pump inhibitor (PPI) followed by laparoscopic antireflux surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Change from baseline GERD symptom at 3 months after antireflux surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease, Antireflux surgery