Comparison of Treatment Outcome and Cost-effectiveness for GERD
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|ClinicalTrials.gov Identifier: NCT03661151|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 13, 2018
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)|
|Actual Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||October 31, 2018|
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
- 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
- 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 ]Evaluation of medical cost based on public insurance system and patients' history
- Complication rate and adverse symptom rate related with antireflux surgery [ Time Frame: Change from baseline GERD symptom at 3 months after antireflux surgery ]Surgical complication and adverse symptom related with antireflux surgery evaluated with GERD symptom questionaire and case records
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661151
|Contact: Sungsoo Park, MD, PhDfirstname.lastname@example.org|
|Contact: Joongmin Park, MD, PhDemail@example.com|
|Korea, Republic of|
|Korea University Anam Hospital||Recruiting|
|Seoul, Korea, Republic of, 02841|
|Contact: Sungsoo Park|
|Principal Investigator:||Sungsoo Park, MD, PhD||Korea University Anam Hospital|