Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 1:12 AM
Study NCT ID:
NCT01260935
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-16', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).', 'timeFrame': '1 year', 'description': 'Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'laparoscopic surgery', 'gastroesophageal', 'reflux'], 'conditions': ['Gastroesophageal Reflux', 'Esophageal Reflux', 'Gastroesophageal Reflux Disease', 'GERD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.', 'detailedDescription': 'The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control\n* \\> 18 years of age and \\< 75 years of age\n\nExclusion Criteria:\n\n* hiatal hernias measuring \\> 7 cm\n* esophageal body amplitude \\< 30 or in two or more segments\n* \\< 40% propagated peristaltic waves\n* GE junction \\> 5 cm above the esophageal hiatus\n* dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy\n* body mass index \\> 40'}, 'identificationModule': {'nctId': 'NCT01260935', 'briefTitle': 'Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Medical Center'}, 'officialTitle': 'A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures', 'orgStudyIdInfo': {'id': 'IR 3722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Laparoscopic Hill', 'interventionNames': ['Procedure: Laparoscopic Hill Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Laparoscopic Nissen', 'interventionNames': ['Procedure: Laparoscopic Nissen Repair']}], 'interventions': [{'name': 'Laparoscopic Hill Repair', 'type': 'PROCEDURE', 'description': 'With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.', 'armGroupLabels': ['Arm A']}, {'name': 'Laparoscopic Nissen Repair', 'type': 'PROCEDURE', 'description': 'With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ralph Aye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Medical Center Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}