Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01268969
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2010-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Two Different Technique in Treatment of Chronic Pilonidal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-03', 'studyFirstSubmitDate': '2010-12-29', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EARLY COMPLICATIONS , HEALING , EARLY RETURN TO WORK', 'timeFrame': '2 years', 'description': 'efficacy of the procedures , short and long term patients satisfactions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pilonidal disease PND'], 'conditions': ['Pilonidal Disease']}, 'referencesModule': {'references': [{'pmid': '14605577', 'type': 'RESULT', 'citation': 'Topgul K, Ozdemir E, Kilic K, Gokbayir H, Ferahkose Z. Long-term results of limberg flap procedure for treatment of pilonidal sinus: a report of 200 cases. Dis Colon Rectum. 2003 Nov;46(11):1545-8. doi: 10.1007/s10350-004-6811-y.'}, {'pmid': '7956585', 'type': 'RESULT', 'citation': 'Fuzun M, Bakir H, Soylu M, Tansug T, Kaymak E, Harmancioglu O. Which technique for treatment of pilonidal sinus--open or closed? Dis Colon Rectum. 1994 Nov;37(11):1148-50. doi: 10.1007/BF02049819.'}, {'pmid': '19198934', 'type': 'RESULT', 'citation': 'el-Khadrawy O, Hashish M, Ismail K, Shalaby H. Outcome of the rhomboid flap for recurrent pilonidal disease. World J Surg. 2009 May;33(5):1064-8. doi: 10.1007/s00268-009-9920-x.'}, {'pmid': '18937009', 'type': 'RESULT', 'citation': 'Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after excision. Dis Colon Rectum. 2008 Dec;51(12):1816-22. doi: 10.1007/s10350-008-9436-8. Epub 2008 Oct 21.'}], 'seeAlsoLinks': [{'url': 'http://www.mans.eun.eg', 'label': 'Mansoura university'}]}, 'descriptionModule': {'briefSummary': 'Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.', 'detailedDescription': 'The authors prospectively studied patients with sacrococcygeal pilonidal disease (SPD) at Mansoura University Hospital, Mansoura, Egypt, .Patients were randomly assigned to undergo either Limberg rhomboid flap or Karydakis flap reconstruction . The follow-up period ranged from 8 months to two years, with the mean follow-up period about 18 months. Surgical findings, complications, recurrence rate and degree of patient satisfaction were compared. This a randomized controlled study to evaluate both rhomboid excision and limberg flap closure versus Karydakis flap for treatment of chronic pilonidal disease.\n\nKarydakis flap reconstruction was performed in conformity with the original procedure described by Karydakis. The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one.\n\nLamberg flap technique: the area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia (Fig3a). The size of the prepared flap was equal to that of the rhomboid area. Meticulous hemostasis was accomplished by electrocauterization. The fasciocutaneous flap was transposed medially so that the defect would be covered without any tension. Sutures were placed between gluteus fascia of the flap and presacral fascia with 2/0 polyglactin to prevent dead space'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATINTS WITH PILONIDAL SINUS\n\nExclusion Criteria:\n\n* PILONIDAL ABSCESS'}, 'identificationModule': {'nctId': 'NCT01268969', 'acronym': 'PND', 'briefTitle': 'Comparison Between Two Different Technique in Treatment of Chronic Pilonidal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Prospective Randomized Trial-comparing Excision and Limberg Flap Closure Versus Karydakis Flap Reconstruction for Treatment of Sacrococcygeal Pilonidal Disease', 'orgStudyIdInfo': {'id': 'AMRO-1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'excision and krydakis reconstruction', 'description': 'The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one', 'interventionNames': ['Procedure: KARYDAKIS GROUP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surgical excision and limberg closure', 'description': 'The area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia . The fasciocutaneous flap was transposed medially so that the defect would be covered without any tension.', 'interventionNames': ['Procedure: Lamberg flap technique']}], 'interventions': [{'name': 'KARYDAKIS GROUP', 'type': 'PROCEDURE', 'otherNames': ['GROUP 1'], 'description': 'The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one', 'armGroupLabels': ['excision and krydakis reconstruction']}, {'name': 'Lamberg flap technique', 'type': 'PROCEDURE', 'otherNames': ['group 2'], 'description': 'The area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia', 'armGroupLabels': ['surgical excision and limberg closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Mansoura', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'waleed askar, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'WALEED ASKAR', 'oldOrganization': 'mansoura university hospital'}}}}