Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-19 @ 7:52 AM
Study NCT ID:
NCT02287935
Status:
COMPLETED
Last Update Posted:
2014-11-11
First Post:
2014-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2014-10-24', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease', 'timeFrame': 'January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals', 'description': 'Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Karydakis procedure', 'Limberg flap', 'recurrent pilonidal sinus'], 'conditions': ['Recurrent Pilonidal Sinus Disease']}, 'referencesModule': {'references': [{'pmid': '26039952', 'type': 'DERIVED', 'citation': 'Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.'}]}, 'descriptionModule': {'briefSummary': 'It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.', 'detailedDescription': 'Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.\n\nIt was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients willing to give written informed consent\n2. There should be recurrent pilonidal sinus\n\n2\\. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus\n\n3\\. International normalizing ratio (INR) less than 1.5\n\n4\\. Prothrombin time (PT) should be less than 15 s\n\n5\\. Partial thromboplastin (PTT) time should be near normal\n\n6\\. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding\n\n7\\. There must be no infection at the time of surgery\n\n\\-\n\nExclusion Criteria:\n\n1. Patients not willing to give informed consent\n2. Age less than 16 years\n3. Patient presenting with conditions mimicking pilonidal sinus\n4. Diabetes mellitus, renal failure, immunosuppression e.g. were excluded\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02287935', 'briefTitle': 'Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Adana Numune Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease', 'orgStudyIdInfo': {'id': 'AdanaNTRH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Limberg flap', 'description': 'Patients were divided into two groups, group 1 were treated with Limberg flap technique', 'interventionNames': ['Procedure: Limberg flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Karydakis procedure', 'description': 'Patients were divided into two groups, group 2 were treated with Karydakis procedure', 'interventionNames': ['Procedure: Karydakis procedure']}], 'interventions': [{'name': 'Limberg flap', 'type': 'PROCEDURE', 'description': 'Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions', 'armGroupLabels': ['Limberg flap']}, {'name': 'Karydakis procedure', 'type': 'PROCEDURE', 'description': 'Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions', 'armGroupLabels': ['Karydakis procedure']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adana Numune Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doc. Dr. Selim Sözen, A. Prof. Dr. İlhan Bali', 'investigatorFullName': 'Mehmet Aziret', 'investigatorAffiliation': 'Adana Numune Training and Research Hospital'}}}}