Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-06 @ 9:35 AM
Study NCT ID:
NCT03661151
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Treatment Outcome and Cost-effectiveness for GERD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)', 'timeFrame': 'Change from baseline GERD symptom at 3 months after antireflux surgery', 'description': 'GERD symptom control rate of surgical and non-surgical treatment for GERD based on the GERD symptom questionaire'}], 'secondaryOutcomes': [{'measure': 'Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)', 'timeFrame': 'Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery', 'description': "Evaluation of medical cost based on public insurance system and patients' history"}, {'measure': 'Complication rate and adverse symptom rate related with antireflux surgery', 'timeFrame': 'Change from baseline GERD symptom at 3 months after antireflux surgery', 'description': 'Surgical complication and adverse symptom related with antireflux surgery evaluated with GERD symptom questionaire and case records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastroesophageal reflux disease', 'Antireflux surgery'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nTreatment outcome of surgery will be evaluated comparing with the outcome of medical treatment before registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Objectively diagnosed GERD\n* Past history of medical treatment with PPI more than 8 weeks at any time before antireflux surgery\n* Patients scheduled to undergo antireflux surgery to treat GERD\n\nExclusion Criteria:\n\n* Other pathologic condition in upper gastrointestinal tract which needs surgical treatment\n* No (or less than 8 weeks) past history of acid suppressive medical therapy with PPI\n* Patients who underwent endoscopic antireflux procedure'}, 'identificationModule': {'nctId': 'NCT03661151', 'briefTitle': 'Comparison of Treatment Outcome and Cost-effectiveness for GERD', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)', 'orgStudyIdInfo': {'id': 'GERD-PPI-ARS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antireflux surgery following PPI', 'description': 'A single cohort with the GERD patients who had acid suppressive medication with proton pump inhibitor (PPI) followed by laparoscopic antireflux surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sungsoo Park', 'role': 'CONTACT'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sungsoo Park, MD, PhD', 'role': 'CONTACT', 'email': 'kugspss@korea.ac.kr', 'phone': '+82-2-920-6772'}, {'name': 'Joongmin Park, MD, PhD', 'role': 'CONTACT', 'email': 'jmpark@cau.ac.kr', 'phone': '+82-2-6299-3124'}], 'overallOfficials': [{'name': 'Sungsoo Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sungsoo Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sungsoo Park', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}