Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-02 @ 12:53 AM
Study NCT ID:
NCT00293995
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2006-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Access Repair of Contralateral Hernias (MARCH Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2006-02-17', 'studyFirstSubmitQcDate': '2006-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of metachronous contralateral inguinal hernia', 'timeFrame': 'Until end of follow-up'}], 'secondaryOutcomes': [{'measure': 'development of recurrent hernia', 'timeFrame': 'Until end of follow-up'}]}, 'conditionsModule': {'conditions': ['Unilateral Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral inguinal hernia\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00293995', 'briefTitle': 'Minimal Access Repair of Contralateral Hernias (MARCH Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'orgStudyIdInfo': {'id': '04SG07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Laparoscopic repair', 'description': 'Laparoscopic repair, with closure of contralateral patent processus vaginalis', 'interventionNames': ['Procedure: Repair of unilateral inguinal hernia']}, {'type': 'OTHER', 'label': 'Open repair', 'description': 'Open repair', 'interventionNames': ['Procedure: Repair of unilateral inguinal hernia']}], 'interventions': [{'name': 'Repair of unilateral inguinal hernia', 'type': 'PROCEDURE', 'armGroupLabels': ['Laparoscopic repair', 'Open repair']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Agostino Pierro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}