Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-19 @ 8:55 AM
Study NCT ID:
NCT02813057
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional loss in lower extremity muscles', 'timeFrame': 'postoperative day 3', 'description': 'Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.'}], 'secondaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'From time of admission to time of discharge an approximate length of three days'}, {'measure': 'Postoperative pain score', 'timeFrame': 'Postoperative 12 hour', 'description': 'Visual analog score assessment of post operative pain'}, {'measure': 'Recurrence rate', 'timeFrame': 'Postoperative 4 months', 'description': 'Number of patients with recurrence'}, {'measure': 'Complications', 'timeFrame': 'Postoperative 1 month', 'description': 'Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '27942876', 'type': 'DERIVED', 'citation': 'Akgul N, Yaprak M, Dogru V, Balci N, Arici C, Mesci A. Quantitative assessment of the impacts of stoppa repair and total extraperitoneal repair on the lower extremity muscular functions in cases of unilateral inguinal hernia: a randomized controlled study. Hernia. 2017 Jun;21(3):377-382. doi: 10.1007/s10029-016-1559-6. Epub 2016 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.', 'detailedDescription': 'The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral inguinal hernia\n\nExclusion Criteria:\n\n* Contralateral hernia repair history\n* Recurrent inguinal hernia\n* Incarceration or strangulation\n* Bilateral inguinal hernia\n* Severe congestive heart failure\n* Severe hypertension\n* Rheumatoid arthritis\n* Systemic or neurologic diseases altering lower extremity functions'}, 'identificationModule': {'nctId': 'NCT02813057', 'briefTitle': 'Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '201203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stoppa repair', 'description': 'Stoppa inguinal hernia repair', 'interventionNames': ['Procedure: Stoppa inguinal hernia repair']}, {'type': 'EXPERIMENTAL', 'label': 'TEP repair', 'description': 'Total extraperitoneal inguinal hernia repair', 'interventionNames': ['Procedure: Total extraperitoneal inguinal hernia repair']}], 'interventions': [{'name': 'Stoppa inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Stoppa inguinal hernia repair', 'armGroupLabels': ['Stoppa repair']}, {'name': 'Total extraperitoneal inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Total extraperitoneal inguinal hernia repair', 'armGroupLabels': ['TEP repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07059', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Ayhan Mesci, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}