Comparison of Treatment Outcome and Cost-effectiveness for GERD

NCT ID: NCT03661151

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-25

Study Completion Date

2020-12-31

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.

Conditions

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Gastroesophageal Reflux

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role collaborator

Kosin University Gospel Hospital

OTHER

Sponsor Role collaborator

Sungsoo Park

OTHER

Sponsor Role lead

Responsible Party

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Sungsoo Park

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sungsoo Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sungsoo Park, MD, PhD

Role: CONTACT

+82-2-920-6772

Joongmin Park, MD, PhD

Role: CONTACT

+82-2-6299-3124

Facility Contacts

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Sungsoo Park

Role: primary

Other Identifiers

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GERD-PPI-ARS

Identifier Type: -

Identifier Source: org_study_id

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