Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-02 @ 5:34 AM
Study NCT ID:
NCT06008535
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10-year Results of Open Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': 'at 10-year follow-up', 'description': 'Inguinal hernia recurrence on clinical examination or in ultrasound'}], 'secondaryOutcomes': [{'measure': 'Chronic pain', 'timeFrame': 'at 10-year follow-up', 'description': 'Chronic pain after open inguinal hernia repair. The pain questionnaire includes questions about pain at rest, on coughing, when rising from lying to sitting position and during physical effort and exercise (yes-or-no questions). If the answer to these questions are positive, then the pain is measured on visual analogue scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrence', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '40551961', 'type': 'DERIVED', 'citation': 'Nikkolo C, Lillsaar T, Vaasna T, Kirsimagi U, Lepner U. Ten-Year Results of Inguinal Hernia Open Mesh Repair. J Abdom Wall Surg. 2025 Jun 9;4:14384. doi: 10.3389/jaws.2025.14384. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The main goal of the research is to evaluate the long-term results of open anterior alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the study is to clarify the incidence of chronic pain and foreign body sensation 10 years after inguinal hernia surgery.\n\nPatients who meet the criteria for inclusion in the study are invited to an appointment, where a questionnaire is filled out, an clinical examination and an ultrasound examination are performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study group consists of patients who were operated on with a primary inguinal hernia in the department of general surgery and plastic surgery between 2008-2013 at the Tartu University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital\n* elective surgery\n* age at least 18 years old at the time of the operation\n* ability to understand the guidelines and willing to participate in the study\n\nExclusion Criteria:\n\n* recurrent hernia\n* strangulated hernia\n* age under 18 years at the time of surgery\n* does not agree to participate in the study\n* does not understand the guidelines. Regarding the last exclusion criterion: since it is an assessment of the remote results of the treatment and probably relatively many of the subjects are very elderly, it may happen that when contacting the patient by phone it turns out that the patient is no longer adequate to make a decision about participating in the study or to answer questions (experienced cerebral infarction, dementia, etc. .) - in this case, the patient is not invited to the appointment.'}, 'identificationModule': {'nctId': 'NCT06008535', 'briefTitle': '10-year Results of Open Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': '10-year Results of Open Inguinal Hernia Repair. A Prospective Study', 'orgStudyIdInfo': {'id': 'TartuUH_Surgery Clinic'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Open inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'state': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Ceith Nikkolo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tartu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'general surgeon', 'investigatorFullName': 'Ceith Nikkolo', 'investigatorAffiliation': 'Tartu University Hospital'}}}}