Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05420818
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2022-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D049291', 'term': 'Seroma'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072829', 'term': 'tetraethylpyrazine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-06-11', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroma formation rate', 'timeFrame': '3 month', 'description': 'The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.'}], 'secondaryOutcomes': [{'measure': 'Chronic pain and quality of life measures', 'timeFrame': '3 month', 'description': 'Detect the presence of chronic pain and measuring quality of life after 3 months using the SF-36'}, {'measure': 'Pain levels', 'timeFrame': '7 day', 'description': 'Pain Scores on the Visual Analog Scale at postoperative 7tht day'}, {'measure': 'Postoperative pain levels', 'timeFrame': '1 day', 'description': 'Pain Scores on the Visual Analog Scale at postoperative 1st day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inguinal Hernia', 'TEP', 'Seroma', 'Laparoscopic Hernia', 'Transversalis fascia inversion'], 'conditions': ['Hernia, Inguinal']}, 'descriptionModule': {'briefSummary': 'According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical or/and radiological diagnosis of primary inguinal hernia\n* EHS type M2 and M3 direct hernias\n* Laparoscopic totally extraperitoneal (TEP) repair\n\nExclusion Criteria:\n\n* Indirect hernias\n* M1 direct hernias\n* Recurrent hernias\n* Patients with previous groin operations on same side\n* Pregnant women\n* Patients who did not accept to participate in the study\n* ASA score of 3 or higher,'}, 'identificationModule': {'nctId': 'NCT05420818', 'briefTitle': 'Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?', 'orgStudyIdInfo': {'id': '2983'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Group', 'description': 'Patients who underwent transversalis fascia inversion during TEP', 'interventionNames': ['Procedure: Transversalis Fascia Inversion']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients who did not undergo transversalis fascia inversion during TEP'}], 'interventions': [{'name': 'Transversalis Fascia Inversion', 'type': 'PROCEDURE', 'otherNames': ['TEP'], 'description': 'This study will be carried out at SBU Istanbul Training and Research Hospital, General Surgery Clinic. Patients diagnosed with M2 and M3 direct primary inguinal hernia according to EHS classification and who will undergo TEP repair surgery will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data of patients in both groups, postoperative pain (VAS values) at postoperative 1st, 7th day and 3rd month, clinical/radiological seroma rate, postoperative pain, QOL, recurrence and other complications will be recorded. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.', 'armGroupLabels': ['Active Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'Fatih', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erol Aydın, MD', 'role': 'CONTACT', 'email': 'erolay@gmail.com', 'phone': '+905322546001'}], 'facility': 'Istanbul Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Erol Aydın', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}