Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-26 @ 6:37 PM
Study NCT ID:
NCT00259961
Status:
COMPLETED
Last Update Posted:
2006-12-25
First Post:
2005-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2006-12-22', 'studyFirstSubmitDate': '2005-11-30', 'studyFirstSubmitQcDate': '2005-11-30', 'lastUpdatePostDateStruct': {'date': '2006-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Gastro -Oesophagal Reflux']}, 'referencesModule': {'references': [{'pmid': '24532685', 'type': 'DERIVED', 'citation': 'Pacilli M, Eaton S, McHoney M, Kiely EM, Drake DP, Curry JI, Lindley KJ, Pierro A. Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children. Arch Dis Child. 2014 Jun;99(6):516-21. doi: 10.1136/archdischild-2013-304279. Epub 2014 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'Long-term results following laparoscopic and open Nissen fundoplication for gastro-oesophageal reflux will be objectively assessed in a selected population of patients already included in a randomized controlled trial comparing the two different techniques. The presence of postoperative symptoms will be evaluated by an independent clinician using an objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by 24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by electrogastrography and 13C-octanoic acid breath test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All patients with gastro - oesophagal reflux -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00259961', 'briefTitle': 'Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'orgStudyIdInfo': {'id': '05SG29'}}, 'armsInterventionsModule': {'interventions': [{'name': 'open fundoplication', 'type': 'PROCEDURE'}, {'name': 'laparoscopic fundopliaction', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pierro Agostino, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}}}}