Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 11:06 PM
Study NCT ID:
NCT00940433
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hernia Repair Four Arm Comparative Study
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': 'C034807', 'term': 'tetra-4-amidinophenoxypropane'}, {'id': 'C072829', 'term': 'tetraethylpyrazine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-14', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient ability to resume domestic activity independently', 'timeFrame': 'daily reporting by the patient'}], 'secondaryOutcomes': [{'measure': 'time of the patient to return to work', 'timeFrame': 'reported by the patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Minimally invasive', 'Inguinal hernia', 'Pro-peritoneal repair'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.', 'detailedDescription': 'The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult male primary inguinal hernia\n\nExclusion Criteria:\n\n* recurrent hernia previous lower abdominal surgery \\[excluding appendectomy\\]'}, 'identificationModule': {'nctId': 'NCT00940433', 'briefTitle': 'Hernia Repair Four Arm Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs', 'orgStudyIdInfo': {'id': '# 90713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open properitoneal', 'description': 'patients undergoing open properitoneal hernia repair', 'interventionNames': ['Procedure: open properitoneal hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lechtenstien repair', 'description': 'Patients undergoing Lechtestien hernia repair', 'interventionNames': ['Procedure: Lechtestien hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic transperitoneal repair', 'description': 'Patients undergoing TAPP repair', 'interventionNames': ['Procedure: Laparoscopic transperitoneal approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lap totally extraperitoneal approach', 'description': 'Patients undergoing TEP approach', 'interventionNames': ['Procedure: Laparoscopic totally extraperitoneal approach']}], 'interventions': [{'name': 'open properitoneal hernia repair', 'type': 'PROCEDURE', 'otherNames': ['extraperitoneal repair'], 'description': 'suprapubic retro-inguinal approach', 'armGroupLabels': ['open properitoneal']}, {'name': 'Lechtestien hernia repair', 'type': 'PROCEDURE', 'otherNames': ['tension free repair'], 'description': 'onlay mesh repair', 'armGroupLabels': ['Lechtenstien repair']}, {'name': 'Laparoscopic transperitoneal approach', 'type': 'PROCEDURE', 'otherNames': ['TAPP'], 'description': 'intraperitoneal insufflation followed by re-exiting to the hernia site', 'armGroupLabels': ['Laparoscopic transperitoneal repair']}, {'name': 'Laparoscopic totally extraperitoneal approach', 'type': 'PROCEDURE', 'otherNames': ['TEP'], 'description': 'avoiding the peritoneum altogether', 'armGroupLabels': ['Lap totally extraperitoneal approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '261112', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Main University hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yasser Hamza, A professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yasser Hamza', 'oldOrganization': 'Faculty of Medicine, University of Alexandria'}}}}