Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 4:21 PM
Study NCT ID:
NCT01551134
Status:
TERMINATED
Last Update Posted:
2012-03-12
First Post:
2012-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018662', 'term': 'Fundoplication'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'whyStopped': 'Fewer patients than anticipated were referred', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-09', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of reflux', 'timeFrame': '12, 24 and 48 months', 'description': 'GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': '30 days', 'description': 'Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.'}, {'measure': 'Inflammatory response', 'timeFrame': 'The first 4 p.o days', 'description': 'indicies of inflammatory response'}, {'measure': 'Parental stress', 'timeFrame': '12 and 24 months', 'description': 'Indicies of parental stress caused by GER pre- and postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux', 'Fundoplication', 'Randomized Controlled Trial', 'General Surgery', 'Child', 'Laparoscopy'], 'conditions': ['Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '35915187', 'type': 'DERIVED', 'citation': 'Fyhn TJ, Kvello M, Edwin B, Schistad O, Pripp AH, Emblem R, Knatten CK, Bjornland K. Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial. Surg Endosc. 2023 Jan;37(1):189-199. doi: 10.1007/s00464-022-09458-6. Epub 2022 Aug 1.'}, {'pmid': '31124989', 'type': 'DERIVED', 'citation': 'Kvello M, Avitsland TL, Knatten CK, Fyhn TJ, Malt U, Emblem R, Bjornland K. Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):818-823. doi: 10.1097/MPG.0000000000002286.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-15 years\n* All patients accepted for primary fundoplication at Oslo University Hospital\n\nExclusion Criteria:\n\n* Age over 16 years\n* Parents not speaking Norwegian or English well\n* Prior fundoplication\n* Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)'}, 'identificationModule': {'nctId': 'NCT01551134', 'briefTitle': 'Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study', 'orgStudyIdInfo': {'id': 'S-03082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open fundoplication', 'description': 'Fundoplication performed with open surgery', 'interventionNames': ['Procedure: Fundoplication']}, {'type': 'EXPERIMENTAL', 'label': 'Lap fundoplication', 'description': 'Primary fundoplication performed by laparoscopic surgery', 'interventionNames': ['Procedure: Fundoplication']}], 'interventions': [{'name': 'Fundoplication', 'type': 'PROCEDURE', 'otherNames': ['Gastroesophageal reflux'], 'description': 'Primary fundoplication', 'armGroupLabels': ['Open fundoplication']}, {'name': 'Fundoplication', 'type': 'PROCEDURE', 'otherNames': ['Gastroesophageal reflux'], 'description': 'Primary fundoplication', 'armGroupLabels': ['Lap fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Kristin Bjornland, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}