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Comparison of Treatment Outcome and Cost-effectiveness for GERD

Sponsor
Sungsoo Park (Other)
Overall Status
Unknown status
CT.gov ID
NCT03661151
Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other), Kosin University Gospel Hospital (Other)
100
Enrollment
1
Location
34.2
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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 :
    Feb 25, 2018
    Anticipated Primary Completion Date :
    Oct 25, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD) [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) [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of 02841

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sungsoo Park, Professor, Korea University Anam Hospital
    ClinicalTrials.gov Identifier:
    NCT03661151
    Other Study ID Numbers:
    • GERD-PPI-ARS
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sungsoo Park, Professor, Korea University Anam Hospital
    Gastroesophageal reflux disease
    Antireflux surgery
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic

    Study Results

    No Results Posted as of Mar 18, 2020