Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-04 @ 5:29 PM
Study NCT ID:
NCT00597194
Status:
COMPLETED
Last Update Posted:
2008-01-17
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059685', 'term': 'Herniorrhaphy'}], 'ancestors': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-16', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recovery after inguinal hernia surgery = time to restore normal activities after surgery', 'timeFrame': 'one week'}], 'secondaryOutcomes': [{'measure': 'degree of postoperative pain', 'timeFrame': '3 days'}, {'measure': 'duration of surgery and hospital stay', 'timeFrame': '1 day'}, {'measure': 'long term surgical result', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia', 'laparoscopic repair', 'open repair', 'randomized'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '17235721', 'type': 'BACKGROUND', 'citation': 'Butler RE, Burke R, Schneider JJ, Brar H, Lucha PA Jr. The economic impact of laparoscopic inguinal hernia repair: results of a double-blinded, prospective, randomized trial. Surg Endosc. 2007 Mar;21(3):387-90. doi: 10.1007/s00464-006-9123-6. Epub 2007 Jan 19.'}, {'pmid': '16862612', 'type': 'BACKGROUND', 'citation': 'Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.'}, {'pmid': '16769338', 'type': 'BACKGROUND', 'citation': 'Schier F. Laparoscopic inguinal hernia repair-a prospective personal series of 542 children. J Pediatr Surg. 2006 Jun;41(6):1081-4. doi: 10.1016/j.jpedsurg.2006.02.028.'}, {'pmid': '19117900', 'type': 'DERIVED', 'citation': 'Koivusalo AI, Korpela R, Wirtavuori K, Piiparinen S, Rintala RJ, Pakarinen MP. A single-blinded, randomized comparison of laparoscopic versus open hernia repair in children. Pediatrics. 2009 Jan;123(1):332-7. doi: 10.1542/peds.2007-3752.'}]}, 'descriptionModule': {'briefSummary': 'We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.', 'detailedDescription': 'Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children.\n\nKey inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted.\n\nStudy type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children.\n\nTarget sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p \\< 0.05.\n\nRecruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral inguinal hernia\n* age age \\> 4 months, \\<16 years\n* fully descended testes\n* study consent signed\n\nExclusion Criteria:\n\n* previous abdominal or inguinal surgery\n* testes not fully descended\n* not healthy enough for day surgery\n* age \\< 4months or \\>16 years\n* study consent not signed'}, 'identificationModule': {'nctId': 'NCT00597194', 'briefTitle': 'Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Children and Adolescents, Finland'}, 'officialTitle': 'Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?', 'orgStudyIdInfo': {'id': '216L2002'}, 'secondaryIdInfos': [{'id': 'T 1040L0007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OH', 'description': 'Inguinal hernia operated using a classic open herniotomy(OH)', 'interventionNames': ['Procedure: Hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LH', 'description': 'Laparoscopic herniorraphy (LH) for inguinal hernia', 'interventionNames': ['Procedure: Hernia repair']}], 'interventions': [{'name': 'Hernia repair', 'type': 'PROCEDURE', 'description': 'Hernia repair laparoscopically (LH) or by open operation (OH)', 'armGroupLabels': ['LH', 'OH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Hospital for Children and Adolescents', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Antti I Koivusalo, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Children and Adolescents,Helsinki,Finland'}, {'name': 'Mikko P Pakarinen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Children and Adolescents,Helsinki,Finland'}, {'name': 'Risto J Rintala, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Children and Adolescents,Helsinki,Finland'}, {'name': 'Christer Holmberg, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital for Children and Adolescents,Helsinki,Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Children and Adolescents, Finland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Christer Holmberg', 'oldOrganization': 'Hospital for Children and Adolescents, Helsinki, Finland'}}}}