Comparison of Treatment Outcome and Cost-effectiveness for GERD

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT03661151
• Lead Sponsor: Sungsoo Park

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.

Study Timeline

• Study Start: 2018-02-25
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-10-25
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of