Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2026-03-13 @ 1:28 PM
Study NCT ID:
NCT00287612
Status:
COMPLETED
Last Update Posted:
2009-09-22
First Post:
2006-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-21', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hiatal hernia', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'control of symptoms', 'timeFrame': '1 year'}, {'measure': 'retching', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GERD', 'Hiatal Hernia', 'Recurrence'], 'conditions': ['Gastroesophageal Reflux Disease', 'Hiatal Hernia']}, 'referencesModule': {'references': [{'pmid': '35171266', 'type': 'DERIVED', 'citation': "van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136."}]}, 'descriptionModule': {'briefSummary': 'This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.', 'detailedDescription': 'This will be a 2-center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact.\n\nSample size calculated on a power of 80% with an alpha level of 0.05 using the recurrence rates demonstrated by our retrospective data produce a number of 159 patients in each arm of the study. Given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. Therefore 180 patients per arm would account for just over 10% attrition.\n\nOne group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. The other group will undergo laparoscopic fundoplication without dividing this membrane. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.\n\nIf 4 consecutive recurrences are found in one group, an interim analysis will be conducted. If a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. Without this occurrence, an interim analysis will be conducted at 180 patients enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under 18 years of age\n* Gastroesophageal Reflux Disease\n\nExclusion Criteria:\n\n1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy\n2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)\n3. Prior operation for congenital diaphragmatic hernia\n4. Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)\n5. Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)'}, 'identificationModule': {'nctId': 'NCT00287612', 'briefTitle': 'Necessity of Esophageal Dissection During Laparoscopic Fundoplication', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children', 'orgStudyIdInfo': {'id': '05 12-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Arms:Lap. Fundo. with Mobilization of the Esophageal Junction', 'interventionNames': ['Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction']}], 'interventions': [{'name': 'Lap. Fundo. with Mobilization of the Esophageal Junction', 'type': 'PROCEDURE', 'description': 'Complete mobilization of the esophageal junction', 'armGroupLabels': ['1']}, {'name': 'Lap. Fundo. without Mobilization of the Esophageal Junction', 'type': 'PROCEDURE', 'description': 'phrenoesophageal membrane left intact', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Shawn D St. Peter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Shawn St. Peter', 'oldOrganization': "Children's Mercy Hospital"}}}}