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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
Sponsor:
Collaborators:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kosin University Gospel Hospital
Information provided by (Responsible Party):
Sungsoo Park, Korea University Anam Hospital

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.

Condition or disease
Gastroesophageal Reflux

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 Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Sungsoo Park, MD, PhD +82-2-920-6772 kugspss@korea.ac.kr
Contact: Joongmin Park, MD, PhD +82-2-6299-3124 jmpark@cau.ac.kr

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Sungsoo Park         
Sponsors and Collaborators
Sungsoo Park
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kosin University Gospel Hospital
Investigators
Principal Investigator: Sungsoo Park, MD, PhD Korea University Anam Hospital

Responsible Party: Sungsoo Park, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03661151     History of Changes
Other Study ID Numbers: GERD-PPI-ARS
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sungsoo Park, Korea University Anam Hospital:
Gastroesophageal reflux disease
Antireflux surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases