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)

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sungsoo Park, MD, PhD; Phone Number: +82-2-920-6772; Email: kugspss@korea.ac.kr
• Study Contact Backup: Name: Joongmin Park, MD, PhD; Phone Number: +82-2-6299-3124; Email: jmpark@cau.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Sungsoo Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)	GERD symptom control rate of surgical and non-surgical treatment for GERD based on the GERD symptom questionaire	Change from baseline GERD symptom at 3 months after antireflux surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)	Evaluation of medical cost based on public insurance system and patients' history	Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery
Complication rate and adverse symptom rate related with antireflux surgery	Surgical complication and adverse symptom related with antireflux surgery evaluated with GERD symptom questionaire and case records	Change from baseline GERD symptom at 3 months after antireflux surgery

Collaborators and Investigators

• Sponsor: Sungsoo Park
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): February 25, 2018
• Primary Completion (Anticipated): October 25, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Gastroesophageal reflux disease; Antireflux surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: GERD-PPI-ARS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No