Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT01020058
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2009-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia
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': 'C072829', 'term': 'tetraethylpyrazine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2009-11-24', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term post operative pain', 'timeFrame': '6 wks, 1 year'}], 'secondaryOutcomes': [{'measure': 'cost-effectiveness of the separate procedures', 'timeFrame': '6wks, 1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '26079901', 'type': 'DERIVED', 'citation': 'Westin L, Wollert S, Ljungdahl M, Sandblom G, Gunnarsson U, Dahlstrand U. Less Pain 1 Year After Total Extra-peritoneal Repair Compared With Lichtenstein Using Local Anesthesia: Data From a Randomized Controlled Clinical Trial. Ann Surg. 2016 Feb;263(2):240-3. doi: 10.1097/SLA.0000000000001289.'}, {'pmid': '23572220', 'type': 'DERIVED', 'citation': 'Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral inguinal hernia\n* suitable for open mesh repair in local anesthesia as well as laparoscopic repair\n* ASA score I-III\n* informed consent\n\nExclusion Criteria:\n\n* ASA score IV (not suitable for TEP)\n* bilateral hernias (laparoscopic repair preferable)\n* recurrent hernia (primary repair affects preferable treatment)\n* large scrotal hernias (not suitable for local anesthesia)\n* earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)'}, 'identificationModule': {'nctId': 'NCT01020058', 'briefTitle': 'Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia', 'orgStudyIdInfo': {'id': '2004:M-360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lichtenstein in local anesthesia (LLA)', 'description': 'Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein', 'interventionNames': ['Procedure: Mesh repair for primary inguinal hernia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TEP', 'description': 'Patient receives a totally extraperitoneal laparoscopic repair', 'interventionNames': ['Procedure: Mesh repair for primary inguinal hernia']}], 'interventions': [{'name': 'Mesh repair for primary inguinal hernia', 'type': 'PROCEDURE', 'otherNames': ['Lichtenstein (LLA)', 'TEP'], 'description': 'Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh', 'armGroupLabels': ['Lichtenstein in local anesthesia (LLA)', 'TEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75436', 'city': 'Enköping', 'country': 'Sweden', 'facility': 'Enköping Hospital', 'geoPoint': {'lat': 59.63607, 'lon': 17.07768}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Staffan Wollert, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala County Council, Sweden', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ursula Dahlstrand', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}