Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00518505
Status:
UNKNOWN
Last Update Posted:
2012-08-15
First Post:
2007-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2007-08-16', 'studyFirstSubmitQcDate': '2007-08-17', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective of this study is to review pre-operative studies and evaluation reports and compare those with post-operative studies and evaluation reports to evaluate outcome following laparoscopic surgery for GERD.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD, laparoscopic surgery'], 'conditions': ['Gastroesophageal Reflux Disorder']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.", 'detailedDescription': 'This study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients must have GERD and must plan to have laparoscopic surgery for GERD.\n* patients must be at least 18 years of age'}, 'identificationModule': {'nctId': 'NCT00518505', 'acronym': 'GERD', 'briefTitle': 'Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': '105238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'I', 'description': 'This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.', 'interventionNames': ['Other: Symptom questionnaire']}], 'interventions': [{'name': 'Symptom questionnaire', 'type': 'OTHER', 'description': 'This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer C. Cooper, B.S.', 'role': 'CONTACT', 'email': 'jcooper@health.usf.edu', 'phone': '813-844-4218', 'phoneExt': '4218'}, {'name': 'Carl B Bowers, R.N.', 'role': 'CONTACT', 'email': 'cbowers@health.usf.edu', 'phone': '813-844-7529', 'phoneExt': '7529'}], 'facility': 'Tampa General Hospital/University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Jennifer C Cooper, B.S.', 'role': 'CONTACT', 'email': 'jcooper@health.usf.edu', 'phone': '813-844-4218', 'phoneExt': '4218'}, {'name': 'Carl B Bowers, R.N.', 'role': 'CONTACT', 'email': 'cowers@health.usf.edu', 'phone': '813-844-7529', 'phoneExt': '7529'}], 'overallOfficials': [{'name': 'Alexander S Rosemurgy, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kenneth Luberice', 'investigatorAffiliation': 'University of South Florida'}}}}