Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05308251
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Hernia Sac Ligation Versus Invagination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D007443', 'term': 'Intussusception'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain levels', 'timeFrame': 'postoperative period before discharge-1 year after discharge', 'description': '10-point Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': 'postoperative period before discharge (mainly the first 24 hours)', 'description': 'hematoma, seroma, wound infection, urinary retention'}, {'measure': 'perioperative outcomes', 'timeFrame': 'postoperative period before discharge (mainly the first 24 hours)', 'description': 'operative time (minutes), hospital stay (days)'}, {'measure': 'recurrence', 'timeFrame': 'postoperative 1 year', 'description': 'Number of patients with hernia recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indirect hernia sac', 'ligation', 'invagination'], 'conditions': ['Hernia, Inguinal', 'Postoperative Pain', 'Recurrence']}, 'referencesModule': {'references': [{'pmid': '29330835', 'type': 'RESULT', 'citation': 'HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.'}, {'pmid': '31165300', 'type': 'RESULT', 'citation': 'Chen DC, Morrison J. State of the art: open mesh-based inguinal hernia repair. Hernia. 2019 Jun;23(3):485-492. doi: 10.1007/s10029-019-01983-z. Epub 2019 Jun 4.'}, {'pmid': '20104504', 'type': 'RESULT', 'citation': 'Stylianidis G, Haapamaki MM, Sund M, Nilsson E, Nordin P. Management of the hernial sac in inguinal hernia repair. Br J Surg. 2010 Mar;97(3):415-9. doi: 10.1002/bjs.6890.'}, {'pmid': '17594052', 'type': 'RESULT', 'citation': 'Delikoukos S, Lavant L, Hlias G, Palogos K, Gikas D. The role of hernia sac ligation in postoperative pain in patients with elective tension-free indirect inguinal hernia repair: a prospective randomized study. Hernia. 2007 Oct;11(5):425-8. doi: 10.1007/s10029-007-0249-9. Epub 2007 Jun 27.'}, {'pmid': '23546863', 'type': 'RESULT', 'citation': 'Othman I, Hady HA. Hernia sac of indirect inguinal hernia: invagination, excision, or ligation? Hernia. 2014 Apr;18(2):199-204. doi: 10.1007/s10029-013-1081-z. Epub 2013 Apr 2.'}, {'pmid': '35725851', 'type': 'DERIVED', 'citation': 'Ciftci AB, Ocak S. A comparison of hernia sac ligation versus invagination in Lichtenstein tension-free mesh hernioplasty: does the type of hernia play a role in outcomes? Hernia. 2022 Aug;26(4):1153-1159. doi: 10.1007/s10029-022-02637-3. Epub 2022 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral uncomplicated indirect hernia\n* elective operations\n* spinal anesthesia\n\nExclusion Criteria:\n\n* Bilateral hernias\n* recurrent cases\n* femoral-scrotal hernias\n* those who refused to give consent\n* those who were given general anesthesia besides spinal anesthesia\n* those who were repaired with a method other than Lichtenstein mesh hernioplasty'}, 'identificationModule': {'nctId': 'NCT05308251', 'briefTitle': 'Comparison of Hernia Sac Ligation Versus Invagination', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Education and Research Hospital'}, 'officialTitle': 'Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?', 'orgStudyIdInfo': {'id': 'SamsunERH2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high ligation', 'description': 'High ligation of the indirect hernia sac is traditional in inguinal hernia repairs. In this arm, patients with indirect inguinal hernia undergoing open mesh herniorrhaphy will have their hernia sac was opened and high ligated.', 'interventionNames': ['Procedure: Lichtenstein Mesh Hernioplasty']}, {'type': 'EXPERIMENTAL', 'label': 'non-ligation', 'description': "In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen.", 'interventionNames': ['Procedure: Lichtenstein Mesh Hernioplasty']}], 'interventions': [{'name': 'Lichtenstein Mesh Hernioplasty', 'type': 'PROCEDURE', 'description': 'The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.', 'armGroupLabels': ['high ligation', 'non-ligation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55090', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Ahmet Burak Ciftci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmet Burak Ciftci', 'investigatorAffiliation': 'Samsun Education and Research Hospital'}}}}