Comparison of Treatment Outcome and Cost-effectiveness for GERD

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03661151

Enrollment

100

Registered

2018-09-07

Start date

2018-02-25

Completion date

2020-12-31

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal reflux disease, Antireflux surgery

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

South Korea

Contacts

Primary ContactSungsoo Park, MD, PhD

kugspss@korea.ac.kr+82-2-920-6772

Backup ContactJoongmin Park, MD, PhD

jmpark@cau.ac.kr+82-2-6299-3124

Outcome results