Comparison of Treatment Outcome and Cost-effectiveness for GERD

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03661151
• Other study ID #: GERD-PPI-ARS
• Status: Recruiting
• Start date: February 25, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Korea University Anam Hospital
• Contact: Sungsoo Park, MD, PhD
• Phone: +82-2-920-6772
• Email: kugspss[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: October 25, 2020
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Sungsoo Park	Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Kosin University Gospel Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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